Search

Current Research on Wet AMD

WET AMD

A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD (PHTHALO-205)

ClinicalTrials.gov Identifier: NCT04331730

Sponsor: Alkahest, Inc.

Purpose: This study will evaluate the efficacy and safety of AKST4290 in combination with aflibercept injections in subjects with newly diagnosed neovascular age-related macular degeneration (nAMD).

Design: Randomized, parallel assignment, double masking

Number of Patients: 100

Inclusion Criteria: Men and women with newly diagnosed active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye, as assessed by a central reader: Has been examined by a retinal specialist and found to be eligible to receive Intravitreal Aflibercept Injection (IAI) in the study eye. No prior treatment for nAMD in the study eye. Study eye has not undergone pars plana vitrectomy or glaucoma filtering surgery. Participation in studies of investigational drugs must have been discontinued within 30 days or 5 half-lives of the drug (whichever was longer) prior to screening. CST thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF). Presence of SRF and/or IRF on SD-OCT. Total lesion size not greater than 12 disc areas (30.48 mm2) (1 disc area = 2.54 mm2) on FA. If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA, SD-OCT, or FP/FAF. No subfoveal fibrosis or atrophy on FA, SD-OCT, or FP/FAF. Active CNV membranes with subfoveal leakage or juxtafoveal leakage too close for laser photocoagulation. BCVA in the study eye between 70 and 24 letters inclusive. Body mass index (BMI) between (and inclusive of) 18 and 40 at screening.

Exclusion Criteria: Participation in studies of investigational drugs within 30 days or 5 half-lives of the drug (whichever was longer) prior to screening. Known hypersensitivity to the active substance or any of the excipients of AKST4290 or aflibercept. Active or suspected ocular or periocular infection and/or active, severe intraocular inflammation. Any form of macular degeneration that is not age-related (e.g., Best's disease, Stargardt's disease, Sorsby's disease). Additional disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (IOP >24) with visual field loss, clinically significant diabetic macular edema, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, high myopia > 6 diopters, or genetic disorders such as retinitis pigmentosa). Presence of RPE tears or rips in the study eye. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate visualization with FP/FAF, FA, or SD-OCT. Intraocular surgery in the study eye within 3 months prior to screening. Aphakia or total absence of the posterior capsule (yttrium aluminum garnet [YAG] laser capsulotomy permitted in an eye with a posterior chamber intraocular lens if performed a minimum of 1 month prior to enrollment) in the study eye. Known allergy to fluorescein sodium. Significant alcohol or drug abuse within past 2 years. Based on ECG reading, subjects with a risk of QT prolongation. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Information: trials@alkahest.com

Study: A Phase II Study of RBM-007 Alone and RBM-007 With Eylea in Subjects With Wet Age-related Macular Degeneration (TOFU)

ClinicalTrials.gov Identifier: NCT04200248

Sponsor: Ribomic USA Inc

Purpose: This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea dosed at every other month, compared to Eylea monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).

Design: Randomized, parallel assignment, double masking

Number of Patients: 81

Inclusion Criteria: Provide signed written informed consent. Male or female 55 years of age or older on the date of signing the consent and able and willing to comply with all treatment and study procedures. Diagnosis of exudative age-related macular degeneration in the study eye, for which previous standard treatment with intravitreal anti-vascular endothelial growth factor agents (at least 4 injections over the past 8 months) has demonstrated incomplete resolution of exudation, as assessed by spectral domain optical coherence tomography. Presence of macular edema or subretinal fluid. Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye. Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye. Visual acuity of 24 letters (20/320) or better in the fellow eye. Reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography.

Exclusion Criteria: Use of any of the following treatments or anticipated use of any of the following treatments to the study eye: Any intravitreal treatment within 4 weeks prior to Baseline (visit 1). Intravitreal or periocular corticosteroid, within 90 days prior to visit 1 (day 1) and throughout the study. Fluocinolone acetonide intravitreal implant, within 12 months prior to visit 1 (day 1) and throughout the study. Visudyne photodynamic therapy, within 90 days prior to visit 1 (day 1) and throughout the study. Uncontrolled or advanced glaucoma, evidenced by an intraocular pressure of >21 mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic hypotony (<6 mmHg) in the study eye. Evidence of any other ocular disease other than wet age-related macular degeneration in the study eye that may confound the outcome of the study History of vitrectomy in the study eye. Need for ocular surgery in the study eye during the course of the study. YAG laser capsulotomy within 30 days prior to visit 1 (day 1) in the study eye. Intraocular surgery, including lens removal or laser, within 90 days prior to visit 1 (day 1) in the study eye.

Information: yusuf.ali@ribomic.com; daniel.pereira@ribomic.com

Study: A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients with Neovascular (Wet) Age-Related Macular Degeneration (DAZZLE)

ClinicalTrials.gov Identifier: NCT04049266

Sponsor: Kodiak Sciences Inc

Purpose: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).

Design: Randomized, parallel assignment

Number of Patients: 368

Inclusion Criteria: Signed informed consent prior to participation in the study. Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD. BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive. Other protocol-specified inclusion criteria may apply.

Exclusion Criteria: CNV secondary to other causes in the Study Eye. Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid. Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss. Active ocular or periocular infection or inflammation. Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye. Uncontrolled glaucoma in the Study Eye. Women who are pregnant or lactating or intending to become pregnant during the study. Stroke or myocardial infarction in the 6-month period prior to Day 1. Uncontrolled blood pressure defined as a systolic value >180 mmHg or diastolic value ≥100 mmHg while at rest. History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. Other protocol-specified exclusion criteria may apply.

Information: KSI-CL-102@kodiak.com

Study: A Study Assessing AR-13503 Implant Alone and in Combination with Aflibercept in Subjects With nAMD or DME

ClinicalTrials.gov Identifier: NCT03835884

Sponsor: Aerie Pharmaceuticals

Purpose: First-in-human study of the safety of AR-13503 sustained release intravitreal implant in subjects with neovascular age-related macular degeneration (nAMD) and subjects with diabetic macular edema (DME).

Design: Randomized, sequential assignment, single

Number of Patients: 102

Inclusion Criteria: Inclusion Criteria for Subjects with Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME): 50 years of age or older. Presence of active subfoveal or juxtafoveal Choroidal Neovascularization (CNV) (any subtype) with leakage affecting the fovea secondary to Age-Related Macular Degeneration (AMD). Best Corrected Visual Acuity (BCVA) in the study eye at Baseline (Day 0): Stage 1: between 65 and 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/50 and 20/640 Snellen equivalent) Stage 2: between 65 and 20 ETDRS letters (20/50 and 20/400 Snellen equivalent). Able and willing to give signed informed consent and follow study instructions. Inclusion Criteria for Subjects with DME: Subjects with Diabetic Macular Edema (DME) must meet all the following criteria to enter into the study: 18 years of age or older. Type 1 or 2 diabetes mellitus with center-involved DME. BCVA in the study eye at Baseline (Day 0): Stage 1: between 65 and 10 ETDRS letters (20/50 and 20/640 Snellen equivalent) Stage 2: between 65 and 20 ETDRS letters (20/50 and 20/400 Snellen equivalent). Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria: Exclusion Criteria for Subjects with Neovascular Age-Related Macular Degeneration (nAMD): Ophthalmic: Use of intravitreal aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks. History of vitreoretinal surgery in the study eye. Any ocular disease in the study eye that in the Investigator and Reading Center's opinion may confound assessment of the macula, affect central vision, confound results, or preclude improvement in visual acuity. Any current or history of periocular or intraocular inflammation or evidence of infection in either eye. Media clarity insufficient to obtain quality fundus and OCT images in the study eye. Systemic: History or current systemic condition that in the Investigator opinion preclude the safe administration of the study treatment or confound results. History of allergy or sensitivity to fluorescein or povidone iodine. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. Participation in an investigational study within 30 days of Screening. Exclusion Criteria for Subjects with DME: Ophthalmic: Use of intraocular or periocular corticosteroids within 6 months, aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks. History of vitreoretinal surgery in the study eye. High risk proliferative diabetic retinopathy in the study eye and related complications. Structural damage to the center or the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the DME. Media clarity insufficient to obtain quality fundus and OCT images in the study eye. Systemic: History or current medical condition that in the Investigator's opinion preclude the safe administration of the study treatment or confound results. History of allergy or sensitivity to fluorescein or povidone iodine. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. Participation in an investigational study within 30 days of Screening.

Information: nramirez@aeriepharma.com, pbraswell@aeriepharma.com

Study: A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects with Wet AMD (ALTISSIMO)

ClinicalTrials.gov Identifier: NCT03953079

Sponsor: Graybug Vision

Purpose: Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB‑102 compared with aflibercept.

Design: Randomized, parallel assignment, single masking

Number of Patients: 220

Inclusion Criteria: Males or females ≥50 years of age. Presence of a CNV lesion secondary to AMD treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab). Demonstrated response to prior anti-VEGF treatment since diagnosis. BCVA of 35 letters or better.

Exclusion Criteria: History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke. Uncontrolled hypertension, diabetes mellitus or IOP. Chronic renal disease. Abnormal liver function. Women who are pregnant or lactating.

Information: vsmith@graybug.com

Paused due to COVID-19 Study: Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)

ClinicalTrials.gov Identifier: NCT04005352

Sponsor: Novartis Pharmaceuticals

Purpose: The study is a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with nAMD (neovascular age related macular degeneration) who have not previously received anti-VEGF (vascular endothelial growth factor) treatment. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria.

Design: Randomized, parallel assignment, triple masking

Number of Patients: 692

Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Male or female patients ≥50 years of age at screening who are treatment naïve. Active choroidal neovascularization (CNV) secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequelae of CNV, eg pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema (study eye). Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield, as seen by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye). Best-corrected visual acuity (BCVA) score between 83 and 38 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye).

Exclusion Criteria: Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye). Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye). Uncontrolled glaucoma defined as intraocular pressure (IOP) >25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye). Ocular treatments: previous treatment with any anti-vascular endothelial growth factor (VEGF) drugs or investigational drugs, intraocular or periocular steroids, macular laser photocoagulation, photodynamic therapy, vitreoretinal surgery, intraocular surgery (study eye). Stroke or myocardial infarction during the 6-month period prior to baseline. Systemic anti-VEGF therapy at any time.

Information: novartis.email@novartis.com

Study: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)

ClinicalTrials.gov Identifier: NCT03834753

Sponsor: Outlook Therapeutics, Inc.

Purpose: This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.

Design: Randomized, parallel assignment, double masking

Number of Patients: 220

Inclusion Criteria: Active primary or recurrent Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye; Best corrected visual acuity of 25-60 letters read (20/60 to 20/320 Snellen equivalent). Study eye must: have active leakage on fluorescein angiogram involving the fovea, have edema involving the fovea, be free of foveal scarring, be free of foveal atrophy.

Exclusion Criteria: Previous use of anti-VEGF or bevacizumab within 6 weeks; Previous subfoveal focal laser photocoagulation in the study eye; Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization; Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year; Active intraocular inflammation (grade trace or above) in the study eye; Current vitreous hemorrhage in the study eye; Polypoidal choroidal vasculopathy (PCV) confirmed by indocyanine green angiography (ICGA); History of idiopathic or autoimmune-associated uveitis in either eye; Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication); Premenopausal women not using adequate contraception; Current treatment for active systemic infection; Known allergy to any component of the study drug or history of allergy to fluorescein or indocyanine green, not amenable to treatment.

Information: ClinicalStudies@outlooktherapeutics.com

Study: Post Intravitreal Injection Topical NSAID vs Patching

ClinicalTrials.gov Identifier: NCT03918590

Sponsor: The New York Eye & Ear Infirmary

Purpose: A prospective randomized trial, to evaluate postinjection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.

Design: Randomized, parallel assignment

Number of Patients: 60

Inclusion Criteria: 18 years of age or older; already scheduled for anti-VEGF injection based on standard of care for disease process. Ability to provide written informed consent; Capable of complying with study protocol. Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care.

Exclusion Criteria: History of past intraocular injection of steroid medication. Experiencing baseline eye pain; monocular; nonstudy eye with VA<20/100. Unwilling or unable to follow or comply with all study related procedures.

Study: Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-1)

ClinicalTrials.gov Identifier: NCT03577899

Sponsor: Chengdu Kanghong Biotech Co., Ltd.

Purpose: The purpose of this clinical study is to evaluate the efficacy and safety of 2 different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea), in subjects with neovascular AMD.

Design: Randomized, parallel assignment, quadruple masking

Number of Patients: 1,140

Inclusion Criteria: Men and women ≥50 years of age at the screening visit; Females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the screening visit; Women of childbearing potential must agree to use a highly effective method of contraception throughout the study. Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and; Have active subfoveal choroidal neovascularization (CNV) lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal fluorescein angiography (FA) leakage, or definite subfoveal fluid by SD-OCT in the study eye at screening; Have a ETDRS BCVA letter score of 78 to 25 in the study eye at screening; Are willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria: Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins; Have participated as a subject in any interventional clinical trial within 1 month (30 days) prior to baseline visit; Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is 1 or more disc areas in size (greater than 2.5 mm2) in the study eye at screening; Have any retinal pigment epithelial tears or rips in the study eye at screening or upon examination at baseline; Have any vitreous hemorrhage in the study eye upon examination at baseline or history of vitreous hemorrhage within 8 weeks prior to screening; Have any other cause of CNV; Have had prior pars plana vitrectomy in the study eye; Have presence of a full thickness macular hole at screening or upon examination at baseline or a history of a full thickness macular hole in the study eye; Have prior trabeculectomy or other filtration surgery in the study eye; Have uncontrolled glaucoma; Have active intraocular inflammation in either eye at screening or upon examination at baseline or a history of uveitis in either eye; Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye; Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period; Have any use of long acting intraocular steroids, including implants, within 6 months prior to day 1, baseline; Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography; Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control; If female, be pregnant (positive urine pregnancy test at screening) or breastfeeding.

Information: panda@cnkh.com

Study: Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-2)

ClinicalTrials.gov Identifier: NCT03630952

Sponsor: Chengdu Kanghong Biotech Co., Ltd.

Purpose: The purpose of this clinical study is to evaluate the efficacy and safety of 2 different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea), in subjects with neovascular AMD.

Design: Randomized, parallel assignment, quadruple masking

Number of Patients: 1,140

Inclusion Criteria: Men and women ≥50 years of age at the screening visit; females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the screening visit; o women of childbearing potential must agree to use a highly effective method of contraception throughout the study. Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and; Have active subfoveal choroidal neovascularization (CNV) lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal fluorescein angiography (FA) leakage, or definite subfoveal fluid by SD-OCT in the study eye at screening; Have a ETDRS BCVA letter score of 78 to 25 in the study eye at screening; Are willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria: Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins; Have participated as a subject in any interventional clinical trial within 1 month (30 days) prior to baseline visit; Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is 1 or more disc areas in size (greater than 2.5 mm2) in the study eye at screening; Have any retinal pigment epithelial tears or rips in the study eye at screening or upon examination at baseline; Have any vitreous hemorrhage in the study eye upon examination at baseline or history of vitreous hemorrhage within 8 weeks prior to screening; Have any other cause of CNV; Have had prior pars plana vitrectomy in the study eye; Have presence of a full thickness macular hole at screening or upon examination at baseline or a history of a full thickness macular hole in the study eye; Have prior trabeculectomy or other filtration surgery in the study eye; Have uncontrolled glaucoma; Have active intraocular inflammation in either eye at screening or upon examination at baseline or a history of uveitis in either eye; Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye. Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period; Have any use of long acting intraocular steroids, including implants, within 6 months prior to day 1, baseline; Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography; any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control; if female, be pregnant (positive urine pregnancy test at screening) or breastfeeding.

Information: panda@cnkh.com

Study: AAVCAGsCD59 for the Treatment of Wet AMD

ClinicalTrials.gov Identifier: NCT03585556

Sponsor: Hemera Biosciences

Purpose: Patients with treatment naive wet AMD will receive an intravitreal anti-VEGF injection at day 0 followed by an intravitreal injection of AAVCAGsCD59 at day 7. Patients will be followed monthly through Month 12 and receive an intravitreal anti-VEGF injection as needed based on an increase in central subfoveal thickness (CST) of >50 micrometers on OCT from day 0, new subretinal hemorrhage on clinical exam, and/or loss of 10 or more ETDRS letters from the previous month exam.

Design: Single group, no masking

Number of Patients: 25

Inclusion Criteria: Men or women 50 years of age or older. Treatment naive Wet AMD with no evidence of subretinal fibrosis under the fovea. Presence of intraretinal and/or subretinal fluid on OCT. Best corrected visual acuity (BCVA) Snellen equivalent 20/25 to 20/400 in the study eye using ETDRS charts at a starting distance of 4m. Adequate pupillary dilation to permit ocular examination and testing. Ability and willingness to return for all scheduled visits and assessments. Understand and comply with the clinical protocol and provide written informed consent prior to any study-related procedure. All fertile men must be willing to use barrier contraception during the study. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception for the duration of the trial. A woman of childbearing potential is defined as any female who has had menses within the last 2 years or has not undergone a hysterectomy or surgical sterilization.

Exclusion Criteria: Wet AMD secondary to non-AMD etiologies. Subretinal hemorrhage that interferes with the ability to adequately measure visual acuity or follow retinal or subretinal fluid collection on OCT. Serous pigment epithelial detachment (PED) that is >50% of the CNV lesion, >400µm in any diameter, or presence of an RPE tear. Presence of polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous retinopathy, or symptomatic vitreomacular adhesion. Previous macular laser photocoagulation for CNV, photodynamic therapy (PDT), ocular radiation, or subretinal surgery for CNV in the study eye. History of conditions in the study eye which might alter visual acuity or interfere with study testing including clinically significant macular edema, central retinal vein occlusion, macular branch retinal vein occlusion, and optic neuropathy. Active uncontrolled glaucoma with IOP>30 mmHg despite treatment with glaucoma medications, cup-to-disc ratio of >0.9, visual field defects secondary to glaucoma that involve the macula, and optic atrophy from glaucoma. Likely candidate for intraocular surgery (including cataract surgery) in the study eye during the clinical trial. Acute or chronic infection in the study eye. History of uveitis unrelated to eye surgery in the study eye or opposite eye requiring treatment with topical corticosteroids or systemic immunosuppression within 24 months of enrollment. Any contraindication to intravitreal injection. Use intravitreal (study eye) corticosteroids within 3 months prior to screening. Any of the following underlying systemic diseases: Unstable or severe cardiovascular disease, eg, congestive heart failure (New York Heart Association Functional class III or IV), myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or critical limb ischemia; Cerebrovascular disease within 12 months prior to screening that impairs the patient's ability to participate in the clinical trial; Dementia or neurodegenerative disease (eg, Alzheimer's disease, Parkinson's disease) of a level that prevents adequate evaluation of the subject during the study; Has an active malignancy or is currently undergoing treatment for an active malignancy at screening, or has a history of malignancy that precludes completion of this 12-month study; Immunocompromised conditions and/or need for immunosuppressive therapy. Any significant poorly controlled illness that would preclude study compliance and follow-up. Current or prior use of any medication known to be toxic to the retina or optic nerve including, but not limited, to chloroquine/hydrochloroquine, deferoxamine, phenothiazines and ethambutol. Previous treatment with any ocular or systemic gene transfer product. Received any investigational product within 120 days prior to screening. Any psychological, familial, sociological, geographical, or other condition that would preclude study compliance and follow-up.

Information: info@hemerabiosciences.com

Study: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants with Neovascular Age-Related Macular Degeneration (TENAYA)

ClinicalTrials.gov Identifier: NCT03823287

Sponsor: Hoffman-La Roche

Purpose: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

Design: Randomized, parallel assignment, triple masking

Number of Patients: 640

Inclusion Criteria: Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye; ability to comply with the study protocol, in the investigator's judgment; for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment.

Exclusion Criteria: Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on day 1; pregnancy or breastfeeding, or intention to become pregnant during the study; CNV due to causes other than AMD in the study eye; any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye; any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study; uncontrolled glaucoma in the study eye; any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye; prior IVT administration of faricimab in either eye; history of idiopathic or autoimmune-associated uveitis in either eye; active ocular inflammation or suspected or active ocular or periocular infection in either eye.

Information: global-roche-genentech-trials@gene.com

Study: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants with Neovascular Age-Related Macular Degeneration (LUCERNE)

ClinicalTrials.gov Identifier: NCT03823300

Sponsor: Hoffman-La Roche

Purpose: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

Design: Randomized, parallel assignment, triple masking

Number of Patients: 640

Inclusion Criteria: Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye; ability to comply with the study protocol, in the investigator's judgment; for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment.

Exclusion Criteria: Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on day 1; pregnancy or breastfeeding, or intention to become pregnant during the study; CNV due to causes other than AMD in the study eye; any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye; any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study; uncontrolled glaucoma in the study eye; any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye; prior IVT administration of faricimab in either eye; history of idiopathic or autoimmune-associated uveitis in either eye; active ocular inflammation or suspected or active ocular or periocular infection in either eye.

Information: global-roche-genentech-trials@gene.com

Study: Intense Treatment Regimen With Intravitreal Aflibercept Injection (I-TRAP)

ClinicalTrials.gov Identifier: NCT03594461

Sponsor: Vitreous-Retina-Macula Consultants of New York

Purpose: This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks.

Design: Randomized, parallel assignment, no masking

Number of Patients: 30

Inclusion Criteria: Age ≥50 years; choroidal neovascularization related to age-related macular degeneration; prior treatment with any anti-VEGF agent for ≥12 months; prior treatment with at least 5 consecutive IAI at baseline with an average treatment interval of maximum 35 days; presence of foveal fluid at most recent clinical visit occurring 30 (+/-5) days following the most recent IAI; willing and able to comply with clinic visits and study-related procedures; provide signed informed consent.

Exclusion Criteria: Monocular patients; patients with a previous history of macular thermal laser or PDT; confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg, cataract, epiretinal membrane, retinal vascular occlusive disease); intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline; history of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye; active intraocular inflammation (grade trace or above) in the study eye; history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye; uncontrolled glaucoma in the study eye (defined as IOP ≥30 mmHg despite treatment with anti-glaucoma medication); history of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment; patients on systemic anti-VEGF treatment; pregnant or breastfeeding women; sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly. *Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Information: sariahpersaud@vrmny.com, rsalgado@vrmny.com

Study: Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO

ClinicalTrials.gov Identifier: NCT03790852

Sponsor: Kodiak Sciences, Inc.

Purpose: This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at 2 dose levels: 2.5 mg and 5 mg.

Design: Randomized, parallel assignment, no masking

Number of Patients: 50

Inclusion Criteria: Wet AMD Cohort: Treatment naïve wet age-related macular degeneration involving the fovea. A lesion area <30 mm2 (12 disc areas) of any lesion type. BCVA ETDRS letter score ≤78 and ≥23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye. Decrease in vision in the study eye determined by the investigator to be primarily the result of wet AMD.

Exclusion Criteria: Wet AMD Cohort: Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye. Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye. Prior intravitreal anti-VEGF therapy in the study eye.

Information: jehrlich@kodiak.com, pablovm@kodiak.com

Study: Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients with Retinal Fluid Despite Frequent Anti-VEGF Injections (MERLIN)

ClinicalTrials.gov Identifier: NCT03710564

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to compare safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those nAMD patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.

Design: Multicenter, randomized, double-masked

Number of Patients: 500

Inclusion Criteria: Sign informed consent; diagnosis of wet age-related macular degeneration (AMD); currently receiving anti-VEGF injections.

Exclusion Criteria: Active infection or inflammation in either eye; significant fibrosis in the study eye; recent ocular surgery; uncontrolled glaucoma; previous treatment with brolucizumab in the study eye; use of medications as specified in the protocol; pregnant, nursing; of child-bearing potential unless using highly effective method of contraception; other protocol-defined inclusion/exclusion criteria may apply.

Information: novartis.email@novartis.com

Study: ADVM-022 Gene Therapy for Wet AMD (OPTIC)

ClinicalTrials.gov Identifier: NCT03748784

Sponsor: Adverum Biotechnologies, Inc.

Purpose: ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require lifelong intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and preserving the vision of patients. ADVM-022 is designed to reduce the current treatment burden and the adverse events (AEs) associated with chronic IVT injections.

Design: Nonrandomized, sequential assignment, open label

Number of Patients: 18

Inclusion Criteria: Age ≥50; diagnosis of neovascular (wet) AMD; BCVA ETDRS Snellen equivalent between ≤20/80 and ≥20/320 for the first (sentinel) patient in each cohort followed by BCVA ETDRS Snellen equivalent between ≤20/40 and ≥20/320 for the rest of the cohort; subjects must be under active anti-VEGF treatment for wAMD and received a minimum of 2 injections within 4 months prior to screening; up to a maximum of 6 injections within 8 months prior to screening; demonstrated a meaningful response to anti-VEGF therapy; willing and able to provide consent.

Exclusion Criteria: History of retinal disease in the study eye other than wet AMD; fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement; history of retinal detachment (with or without repair) in the study eye; history of vitrectomy, trabeculectomy, or other filtration surgery in the study eye; uncontrolled glaucoma in the study eye; any prior treatment with photodynamic therapy or retinal laser for the treatment of wet AMD and any previous therapeutic radiation in the region of the study eye; any previous intraocular or periocular surgery on the study eye within 6 months; acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months; uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg.

Information: stong@adverum.com

Study: A Phase III Study to Evaluate the Port Delivery System Implant with Ranibizumab Compared with Monthly Ranibizumab Injections in Participants with Wet Age-Related Macular Degeneration (Archway)

ClinicalTrials.gov Identifier: NCT03677934

Sponsor: Hoffman-La Roche

Purpose: Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

Design: Randomized, parallel assignment, single masking

Number of Patients: 360

Inclusion Criteria: Age ≥50 years, at time of signing Informed Consent Form. Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit. Previous treatment with at least 3 anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit. Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis. Best-corrected visual acuity (BCVA) of 34 letters or better.

Exclusion Criteria: Subfoveal fibrosis or subfoveal atrophy in study eye. Subretinal hemorrhage that involves the center of the fovea in study eye. History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye. Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in study eye. Previous intraocular device implantation in study eye. Previous laser (any type) used for AMD treatment in study eye. Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye. Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye. CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye. Uncontrolled blood pressure. History of stroke within the last 3 months prior to informed consent. Uncontrolled atrial fibrillation within 3 months of informed consent. History of myocardial infarction within the last 3 months prior to informed consent. History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator. Current systemic treatment for a confirmed active systemic infection. Chronic use of oral corticosteroids. Active cancer within 12 months of randomization. Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals).

Information: global-roche-genentech-trials@gene.com

Study: Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF

ClinicalTrials.gov Identifier: NCT03071055

Sponsor: Southeast Clinical Research Associates, LLC

Purpose: This is a 24 week open label study to assess the efficacy of biweekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.

Design: Nonrandomized, single group assignment, open label

Number of Patients: 20

Inclusion Criteria: Age >50 years, exudative age related macular degeneration in study eye involving the fovea, Best Corrected Visual Acuity (by ETDRS) letter score in study eye of <85 and >24 (approximate Snellen equivalent 20/20 to 20/320), persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye, at least 30 days from last intravitreal anti-VEGF injection in the study eye.

Exclusion Criteria: Patient who are receiving systemic anti-VEGF or proangiogenic therapy, patients on chronic high doses corticosteroid therapy (>than 10 mg of oral prednisone or equivalent greater than 10 days), patients on chronic immunosuppressant therapy, patients on drugs known to have toxic side effects on the retina, eg, hydroxychloroquine, history of intravitreal corticosteroids in study eye within 4 months of baseline, uncontrolled hypertension (defined as systolic >180 mm Hg and/or diastolic >100 mm Hg while patient is sitting), history of stroke or APTC event in the previous year, any intraocular surgery in study eye within 90 days of baseline, presence of vitreomacular traction in study eye, presence of significant epiretinal proliferation in study eye, evidence of active infection in either eye, uncontrolled glaucoma in the study eye defined as a pressure >25 mmHg on maximal medical therapy.

Information: aprice@ceenta.com, ana@ceenta.com

Study: DECO: Open-Label Study of Intravitreal ICON-1 in Patients with Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

ClinicalTrials.gov Identifier: NCT03452527

Sponsor: Iconic Therapeutics, Inc.

Purpose: The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.

Design: Randomized, parallel assignment, open label

Number of Patients: 20

Inclusion Criteria: Males or females of any race, ≥50 years of age, active primary CNV secondary to AMD in the study eye.

Exclusion Criteria: Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins, any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months, vitrectomy in the study eye.

Information: clinicaltrials@iconictherapeutics.com

Study: ZEBRA: Ziv-aflibercept Efficacy in Better Regulating AMD

ClinicalTrials.gov Identifier: NCT03423823

Sponsor: Kapil Kapoor

Purpose: This is a randomized, open-label, interventional, controlled study to determine the effects of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control anti-vascular endothelial growth factor ("anti-VEGF") injections (bevacizumab, ranibizumab, or aflibercept).

Design: Randomized, parallel assignment, no masking

Number of Patients: 100

Inclusion Criteria: Are age 50-99; have neovascular AMD with an eye undergoing maintenance treatment with 1 or more of the following anti-VEGF drugs: bevacizumab, ranibizumab, or aflibercept; have an eye undergoing treatment that is of low visual potential (20/200 Snellen equivalent or worse) and the contralateral eye must have better visual potential; are willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments; have received an intravitreal injection of 1 of the drugs listed above within 120 days of day 1 of the trial. Both males and females will be enrolled.

Exclusion Criteria: Active intraocular inflammation or infection; history of vitreous hemorrhage within 3 months prior to day 1 of the study; Uncontrolled ocular hypertension or glaucoma in the study eye (defined as IOP >25 mmHg or a Cup to Disc ratio >0.8 despite treatment with anti-glaucoma medication) or any such condition which the investigator feels may warrant a glaucoma filtering surgery during the study; history of stroke within the last 3 months prior to day 1 of the study; History of myocardial infarction within the last 3 months prior to day 1 of the study; Undergone intraocular surgery or laser treatments within the last 3 months; significant epiretinal membrane (ERM) or vitreomacular traction (VMT) causing distortion of macular anatomy; No use of ocular corticosteroids within the last 6 months and no use of systemic corticosteroids at a dose of >10 mg/day; Not have active malignancies within the last 12 months except appropriately treated carcinoma in situ of the cervix, melanoma, and prostate cancers treated with a curative intent; Inability to comply with study or follow-up procedures; Women who may become pregnant or lactating or intend to become pregnant during the study; Women who are of childbearing potential, including women who have had tubal ligation, must have a blood test within 21 days prior to day 1 of the study. A woman is considered to not be of childbearing potential if she is postmenopausal or has undergone hysterectomy and/or bilateral oophorectomy. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Information: research@wagnerretina.com

Study: Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0 mg as a Predictor of Long-Term Results

ClinicalTrials.gov Identifier: NCT01657669

Sponsor: Retina Research Institute, LLC

Purpose: This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).

Design: Single Group Assignment, No Masking, Treatment

Number of Patients: 22

Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age 50 years and above. Choroidal neovascularization secondary to AMD with central retinal thickness greater than or equal to 300 um. Best corrected visual acuity in the study eye between 20/40 and 20/400 using an ETDRS chart.

Exclusion Criteria: Pregnancy (positive urine pregnancy test) or lactation. Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Participation in a study or an investigational drug or device within the past 30 days prior to enrolling in the study. Presence of significant subfoveal fibrosis or atrophy. Previously treated subjects: Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline More than 6 prior treatments with anti-VEGF therapy in the study eye within 1 year. Prior treatment with PDT within the past 3 months or more than 2 prior PDT treatments. Prior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone in the study eye within 6 months of baseline. Prior treatment with dexamethasone in the study eye within 30 days prior to baseline. Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline. History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye. Active intraocular inflammation (grade trace or above) in the study eye. Current vitreous hemorrhage in the study eye. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. Uncontrolled glaucoma in the study eye (defined as IOP greater than or equal to 30 mmHg despite treatment with anti-glaucoma medication). History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment. History of allergy to fluorescein, ICG or iodine, not amenable to treatment. History of retinal pigment epithelial tear or rip.

Study: NEAMES: Episcleral Brachytherapy for the Treatment of Wet AMD

ClinicalTrials.gov Identifier: NCT02988895

Sponsor: Salutaris Medical Devices, Inc.

Purpose: This is a prospective, single-arm, open-label, safety, usability and tolerability trial of Strontium 90 (Sr90) beta radiation episcleral brachytherapy in subjects receiving aflibercept therapy pro re nata (PRN) for the treatment of early neovascular age-related macular degeneration (nAMD) lesions. Secondary aims are to observe clinical outcomes of area of leakage, subretinal fluid, lesion size, visual acuity, and anti-vascular endothelial growth factor (anti-VEGF) treatment burden.

Design: Single Group, No Masking, Treatment

Number of Patients: 20

Inclusion Criteria: Diagnosis of CNV due to nAMD; Male or female aged 50 years or older; Documented continued care for nAMD since diagnosis; Patients must have demonstrated clinical or OCT/angiographic evidence that, in the investigator's opinion, requires treatment with anti-VEGF therapy; BCVA 20/40 - 20/200 Snellen equivalent in study eye; Actively leaking CNV as determined by FA.

Exclusion Criteria: Females of child-bearing potential (defined as <2 years postmenopausal) CNV other than due to nAMD; Subfoveal lesion hemorrhage obscuring >50% of lesion; CNV lesion with greatest linear dimension >2mm as determined by Intravenous Fluorescein angiography; Presence of subretinal fibrosis in the study eye; Existing Retinal Pigment Epithelial tear; Previous treatment (excluding vitamins) for nAMD in the study eye other than aflibercept anti-VEGF therapy in the last 6 months; A change in anti-VEGF agent in the previous 2 administrations; Anticipate a change to the anti-VEGF agent during the conduct of the study; Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction; Other clinically significant ocular co-morbidity including, but not limited to, optic glaucoma, optic neuropathy of any cause, maculopathy/retinopathy of any cause other than nAMD, and scleritis; Refractive error of -6D or greater (spherical equivalent) or demonstrated myopic degeneration; Media opacity sufficient to preclude adequate fundoscopy, OCT or angiography; Uncontrolled systemic diseases (eg, controlled hypertension is acceptable); Type I or type II diabetes mellitus; Clinically significant previous radiation to the eye; Unable to discontinue anticoagulation or dual anti-platelet therapy for 7 days before and after the study intervention.; Patient unsuitable for IV or local anesthesia; Any contraindication to anti-VEGF, fluorescein, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study; Active ocular or periocular infection or intraocular inflammation; Only eligible eye is the best seeing eye; Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct.

Information: mdrew@salutarismd.com

Study: Carbidopa-levodopa in Neovascular AMD

ClinicalTrials.gov Identifier: NCT03022318

Sponsor: Robert W. Snyder, MD, PhD, PC

Purpose: The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD and measure the effects on visual acuity and retinal abnormalities due to "wet" (neovascular) AMD.

Design: Nonrandomized, Parallel Assignment, No Masking, Treatment

Number of Patients: 52

Inclusion Criteria: A diagnosis of AMD with choroidal neovascularization (CNV) in 1 eye; not previously treated with anti-VEGF injections; normal or dry AMD of any grade in the second eye; age 50 to 85; willingness to maintain AREDS vitamin supplements throughout the study, or remain off these supplements for the duration of the study, if not taking them prior to the study; signed informed consent.

Exclusion Criteria: Any current use of L-DOPA containing medication or dopamine agonist medication, or any planned use of any of these agents, except for study medication, during the study; concurrent use of monoamine oxidase (MAO) inhibitors; any eye condition, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery; BCVA worse than 20/160 in the better eye; wet AMD in the second eye; neurologic conditions which can impair vision; Parkinson disease; significant orthostatic hypotension, defined as a drop in systolic blood pressure, immediately upon changing from the supine to standing position, of >19 mmHg, or a symptomatic drop in systolic blood pressure, immediately upon changing from the supine to standing position; significant ECG abnormalities, as judged by the investigator; estimated glomerular filtration rate (eGFR) <20 mL/min; Liver enzymes >3x the upper limit of normal; HbA1c >9.0; any other significant lab abnormalities, as judged by the investigator; women of childbearing potential; known retinal hemorrhage; subjects who are not fluent in English.

Information: tcfaganmd@gmail.com; rsnyder781@gmail.com

Study: Dose Ranging Study of Carbidopa-levodopa

ClinicalTrials.gov Identifier: NCT03023059

Sponsor: Robert W. Snyder, MD, PhD, PC

Purpose: The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD who are already on treatment with anti-VEGF intraocular injections, and measure the effects on visual acuity, retinal abnormalities due to "wet" AMD, and document the number of anti-VEGF injections required during the study.

Design: Single Group, No Masking, Treatment

Number of patients: 52

Inclusion Criteria: A diagnosis of AMD with choroidal neovascularization (CNV) in 1 eye; not previously treated with anti-VEGF injections, OR on anti-VEGF injections for at least 3 months, and meets criteria for a repeat injection, OR patients, who have completed Study 001, may enter this trial at the point of initiation of the month of treatment with the dose of carbidopa-levodopa, that they received in Study 001; normal or dry AMD of any grade in the second eye; willingness to maintain AREDS vitamin supplements throughout the study, or remain off these supplements for the duration of the study, if not taking them prior to the study; informed consent at baseline.

Exclusion Criteria: Any current use of L-DOPA containing medication or dopamine agonist medication, or any planned use of any of these agents, except for study medication, during the study; concurrent use of monoamine oxidase (MAO) inhibitors; any eye conditions, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery; BCVA worse than 20/60 in the better eye; wet AMD in the second eye; neurologic conditions which can impair vision; Parkinson’s Disease; significant orthostatic hypotension, defined as a drop in systolic blood pressure, immediately upon changing from the supine to standing position, of >19 mmHg, or a symptomatic drop in systolic blood pressure, immediately upon changing from the supine to standing position; significant ECG abnormalities, as judged by the investigator; estimated glomerular filtration rate (eGFR) ,20 ml/min; liver enzymes >3x the upper limit of normal; HbA1C>9.0; any other significant lab abnormalities, as judged by the investigator; women of childbearing potential; known retinal hemorrhage; subjects who are not fluent in English.

Information: tcfaganmd@gmail.com, rsnyder781@gmail.com

Study: IAI-OCTA: A study of OCT-Angiography Analysis Efficacy

ClinicalTrials.gov Identifier: NCT03022292

Sponsor: University of California, Los Angeles

Purpose: This study is utilizing a new, FDA approved, nonstandard of care technology (OCT-Angiography by Optovue) to image and evaluate the treatment outcomes of using standard of care Intravitreal Aflibercept Injections for their approved use in patients diagnosed with neovascular AMD who are naive to previous Anti-VEGF therapies.

Design: Single Group Assignment, No Masking

Number of Patients: 30

Inclusion Criteria: Older than 50; willing to participate in the study and able to follow study criteria and protocol; the study eye is treatment naïve regarding treatment of neovascular AMD; subject is willing and able to comply with clinic visits and study-related procedures; subject is able to provide signed informed consent; subject is able to understand and complete study-related questionnaires; subject is not currently involved with any other clinical study; BCVA with ETDRS Snellen equivalent of 20/400 or better and 20/32 or worse; sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA and fundus photography; IOP of 25 mmHg or less in the study eye, with or without use of ocular hypotensive agents; prior focal corticosteroid treatment is allowed, as long as the study eye is not involved. However prior (within 90 days of day 0) or current systemic corticosteroid therapy (oral or intravenous corticosteroid treatment) is not permitted.

Exclusion Criteria: Any prior treatment of neovascular AMD in the eye proposed for enrollment including previous anti-vascular endothelial factor (anti-VEGF) therapy, photodynamic therapy (PDT), radiation therapy, corticosteroid treatment, surgical treatment for CNV, thermal laser treatment, and any other prior intravitreal treatment for neovascular AMD (except minerals and vitamins); known serious allergies to aflibercept, fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation, topical anesthetic, or sterilizing solution (eg, Betadine Solution); prior or current systemic anti-VEGF therapy; pregnant or breast-feeding women; sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly); contraindication to pupillary dilation in study eye; any condition (including inability to read visual acuity charts, or language barrier) that may preclude subjects ability to comply with the study protocol and requirements; presence of any advanced systemic condition or end-stage disease, such as advanced Alzheimer Syndrome, end-stage cancer, etc., which will likely prevent subject from completing study; previous therapeutic radiation in the region of the study eye; prior retinal pigment epithelial (RPE) tear in study eye; prior ocular surgery (except YAG laser capsulotomy) for study within the past 90 days; anticipated ocular surgery 9except YAG laser capsulotomy) for the next 12 months; prior vitrectomy in the study eye; presence of any causes of CNV and PED other than due to AMD or presence of ocular disease other than AMD affecting study eye, ie presumed ocular histoplasmosis syndrome, android streaks, pathologic myopia.

Information: harmon@jsei.ucla.edu, downey@jsei.ucla.edu

Study: RGX-314 Gene Therapy for Neovascular AMD Trial

ClinicalTrials.gov Identifier: NCT03066258

Sponsor: Regenxbio Inc.

Purpose: To test RGX-314’s ability to treat neovascular AMD.

Design: Nonrandomized, sequential assignment, no masking, treatment

Number of Patients: 18

Inclusion Criteria: Patients ≥50 years with a diagnosis of subfoveal CNV secondary to AMD in the study eye receiving prior intravitreal anti-VEGF therapy; BCVA between ≤20/100 and ≥20/400 (≤53 and ≥19 Early Treatment Diabetic Retinopathy Study [ETDRS] letters) for the first patient in each cohort followed by BCVA between ≤20/63 and ≥20/400 (≤75 and ≥35 ETDRS letters) for the rest of the cohort; history of need for and response to anti-VEGF therapy; response to anti-VEGF at trial entry (assessed by SD-OCT at week 1); must be pseudophakic (status post cataract surgery) in the study eye; AST/ALT <2.5×ULN; TB <1.5×ULN; PT <1.5×ULN; Hb >10 g/dL (males) and >9 g/dL (females); Platelets >100×10^3/µL; eGFR >30 mL/min/1.73 m^2; must be willing and able to provide written, signed informed consent.

Exclusion Criteria: CNV or macular edema in the study eye secondary to any causes other than AMD; any condition preventing visual acuity improvement in the study eye, eg, fibrosis, atrophy, or retinal epithelial tear in the center of the fovea; active or history of retinal detachment in the study eye; advanced glaucoma in the study eye; history of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to screening; presence of an implant in the study eye at screening (excluding intraocular lens); myocardial infarction, cerebrovascular accident, or transient ischemic attacks within the past 6 months; uncontrolled hypertension (systolic blood pressure [BP] >180 mmHg, diastolic BP >100 mmHg) despite maximal medical treatment.

Information: patientadvocacy@regenxbio.com

Study: Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD

ClinicalTrials.gov Identifier: NCT02599064

Sponsor: RXi Pharmaceuticals

Purpose: To evaluate the safety, tolerability and clinical activity of RXI-109 administered by intravitreal injection to reduce the progression of subretinal fibrosis in subjects with advanced neovascular age-related macular degeneration.

Design: Safety/efficacy, open label, single group, treatment

Number of Patients: 9

Inclusion Criteria: Subjects presenting with advanced NVAMD in the study eye with BCVA ≤20/200 potentially due to subretinal fibrosis involving the fovea; BCVA ≥20/800 in the contralateral eye and better than the study eye; ≥50 years of age; subfoveal CNV of any type.

Exclusion Criteria: Presence of other causes of CNV including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.

Information: clinicaloperations@rxipharma.com

Study: PREVENT: Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration

ClinicalTrials.gov Identifier: NCT02140151

Sponsor: Southern California Desert Retinal Consultants

Purpose: To determine whether quarterly injections of ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration.

Design: Randomized, Efficacy, Parallel Assignment, Single-Blind, Prevention

Number of Patients: 100

Inclusion Criteria: Nonexudative age-related macular degeneration (AMD) in 1 eye (study eye); history of exudative AMD in 1 eye only (fellow eye) diagnosed within 5 years of study enrollment.

Exclusion Criteria: Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥-8 diopters or axial length of ≥25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), etc.

Information: mlalezary@desertretina.com

19 views0 comments