Study: A Staged Study of the Safety and Effectiveness of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Dry Age-related Macular Degeneration
ClinicalTrials.gov Identifier: NCT03178149
Sponsor: Astellas Institute for Regenerative Medicine
Purpose: This study is looking at a new treatment for slowing or reversing dry AMD, called ASP7317. ASP7317 is a specially created type of cells derived from stem cells. ASP7317 cells are injected into the macula of the eye. Immunosuppressive medicines (called IMT) are also taken around the time of injection of the cells to prevent the body from rejecting them.
Design: Randomized, parallel assignment, no masking
Number of Patients: 150
Inclusion Criteria: Subject has atrophy secondary to AMD in the study eye. Subject has the border of the area of definite decreased autofluorescence (DDAF) in the study eye, within the vascular arcades (criterion not applicable for subjects in dose escalation stage). Subject has a best corrected visual acuity (BCVA) score ≤37 early treatment diabetic retinopathy study (ETDRS) letters, in the study eye, at the second assessment during the screening visit between 4 and 23 ETDRS letters. In the dose escalation stage for the first dose cohort only, the study eye must be between light perception and ≤ 23 ETDRS letters at the second assessment during the screening visit. Subject has stable BCVA, in the study eye, to ensure stability of the visual acuity measures for study analyses (criterion not applicable for subjects in dose escalation stage). Subject has spectral domain-optical coherence tomography (SD-OCT) scans obtained of the study eye at the screening visit of suitable quality for grading retinal microstructures. Subject, at the screening visit, must have in the study eye an area with reduced retinal function and evidence of structural retinal preservation between the border of the area of atrophy and the vascular arcades, as determined by the subject selection committee (SSC) (criterion not applicable for subjects in dose escalation stage). Subject is recommended by the SSC for trial participation.
Exclusion Criteria: The following conditions are exclusionary if present in the study eye, unless otherwise specified. Foveal sparing as determined by either of the following methods (criterion not applicable for subjects in dose escalation stage): Any of the 9 loci in central square of the macula test grid with ≥ 0 dB sensitivity based on microperimetry testing at the prescreening or screening visit assessments. Presence of potentially viable photoreceptors, as evidenced by presence of ellipsoid zone (EZ), ≤ 250. Subject has evidence of prior or active choroidal neovascularization (CNV). Evidence of CNV will be assessed by the image reading center through review of the screening fundus photographs, fluorescein angiography (FA) and SD-OCT images. Evidence of CNV seen on 1 or more imaging modality is exclusionary. Subject has macular atrophy due to causes other than AMD. Subject has pathologic myopia defined as a spherical equivalent of > 8.00 diopters or axial length > 28 mm at the prescreening or screening visit, or myopic macular degeneration. Subject has a contraindication to pupil dilation. Subject has any other current sight-threatening ocular disease. Subject has presence of a posterior staphyloma. Subject has a current or prior history of optic neuropathy. Subject has presence of a macular hole. Subject has presence of macular schisis. Subject has a current or prior history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serous choroidopathy, diabetic retinopathy, diabetic macular edema, vasoocclusive disease or other retinal vascular disease (e.g., compromised blood-retinal barrier) or retinal degenerative disease other than AMD. Subject has a prior history of retinal detachment within the vascular arcades. Subject has nevus of Ota (oculodermal melanocytosis), a choroidal pigmented lesion showing characteristics associated with high risk of malignancy (e.g., orange pigmented or elevated lesions) or a choroidal nevus within the macula. Subject has presence of submacular scarring. Subject has presence of an ocular toxoplasmosis scar or suspected active infection (or presence of elevated immunoglobulin M [IgM] toxoplasmosis titer). Subject has an abnormality of vitreoretinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) which can interfere with measurement of macular thickness or with the potential for macular structural damage. Subject has an intraocular pressure (IOP) of < 6 mmHg at the screening or first baseline (day -21) visits. Subject has presence of glaucomatous optic atrophy or uncontrolled intraocular pressure (IOP), or is using more than 2 agents to control IOP. Subject has active or history of uveitis. Subject has obscured ocular media opacity (e.g., corneal scars, lens opacities, vitreous abnormalities, etc.) at the screening or first baseline (day -21) visits such that reliable evaluations of the posterior segment cannot be performed. Subject has any other current ocular condition that can interfere with the assessment of disease progression including but not limited to accumulation of intraretinal fluid, subretinal fluid, sub-retinal pigment epithelial/epithelium (RPE) fluid or cyctoid macular edema. Subject has monocular vision. Subject has a history of ocular cancer in either eye.
Study: First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT04246866
Sponsor: Gemini Therapeutics, Inc.
Purpose: The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 12
Inclusion Criteria: At least 50 years old at the time of signed informed consent. Genetic variant eligibility. Able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure. Best corrected visual acuity (BCVA) in study eye between 5-35 letters. Confirmed diagnosis of central GA in the study eye and eligible total GA lesion size.
Exclusion Criteria: Carriers of specified high-genetic risk AMD variants. Presence of the following ocular conditions - in the study eye: Exudative AMD or choroidal neovascularization (CNV); Any ocular disease or condition that could impact the subject's ability to participate in the study or be a contraindication to IVT injection; Intraocular surgery (including intraocular lens replacement surgery) within 3 months prior to consent. Presence of any of the following ocular conditions - in either eye: History of herpetic infection; Ongoing treatment with antiangiogenic therapies in the fellow eye or completed treatment in the study eye. Any prior or ongoing medical condition (e.g. ocular other than dry AMD, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period. Female subjects must not be pregnant or lactating. Current use of medications known to be toxic to the lens, retina, or optic nerve.
Study: Carbidopa-Levodopa in Dry AMD With Geographic Atrophy
ClinicalTrials.gov Identifier: NCT03451500
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. The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Dry AMD and Geographic Atrophy, and measure the effects on visual acuity, area of geographic atrophy and other retinal abnormalities due to "dry" AMD.
Design: Parallel assignment, randomized, prospective, placebo-controlled
Number of Patients: 7
Inclusion Criteria: A diagnosis of dry AMD with geographic atrophy in 1 or both eyes. In patients with geographic atrophy in both eyes, the eye with the larger area of geographic atrophy will be designated eye A and the eye with the smaller area of geographic atrophy will be designated eye B. Normal or dry AMD of any grade in the second eye; Age 50-85 years; 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 previous or 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 20/100 in the eye with better BCVA; Current, or history of, neovascular AMD in either 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.
Study: Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)
ClinicalTrials.gov Identifier: NCT04065490
Sponsor: LumiThera, Inc.
Purpose: This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 96
Inclusion Criteria: Male or female at least 50 years of age at Screening visit. ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32). *If the subject meets this criterion at the Screening Visit, but the Baseline BCVA letter score is between 48 and 77, the subject may be entered in the study. Diagnosis of dry AMD as defined by the presence of the following: Drusen that are intermediate in size or larger (63 μm or larger in diameter) with at least a few (3) being regular drusen and not pseudodrusen and/or geographic atrophy (GA) visible on 2 of the following: color fundus images, OCT and/or FAF, to be confirmed by the reading center. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study. Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines.
Exclusion Criteria: Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center): Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane; Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE); Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage); Subretinal and sub-RPE fibrovascular proliferation; Disciform scar (subretinal fibrosis). Presence of center involving GA within the central ETDRS 1 mm diameter at Screening, to be confirmed by the reading center. Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 24 months. Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require surgery in the study eye in the next 24 months. Invasive eye surgery (eg cataract, capsulotomy) on a qualifying eye within 3 months prior to screening. Ocular disorder or disease that partially or completely obstructs the pupil (eg posterior synechia in uveitis). Visually significant disease in any ocular structure apart from dry AMD (eg diabetic macular edema, glaucoma (using >2 eye drop medications, uncontrolled IOP and/or central/paracentral visual field loss), glaucoma surgery, active uveitis, active vitreous disease, intraocular tumor, retinal vascular diseases). Ocular disorder or disease other than dry AMD that could cause drusen (glomerulonephritis Type 2, Autosomal dominant drusen), GA (North Carolina dystrophy) or mitochondrial diseases (parafoveal petaloid GA, Stargardt disease). Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (eg amblyopia, stroke, nystagmus). Serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study. Presence of or history of malignancy within the past 5 years other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ. Is non-ambulatory. Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if they have a history of light activated CNS disorders (eg epilepsy, migraine). Use of any photosensitizing agent (eg topicals, injectables, oral) within 30 days of treatment without consulting subject's physician. History of drug, alcohol or substance abuse within 3 months prior to Screening. Has received an investigational drug or treatment with an investigational device within 3 months prior to Screening. If on any antioxidant or vitamin Age-Related Eye Disease Study (AREDS) supplement for dry AMD, has not been stabilized for a minimum of 1 month prior to Screening. Subjects are considered to be stable if they are taking the AREDS supplements consistently as prescribed by their treating doctor. Has received Low Vision Rehab/Therapy within 30 days prior to Screening or intends to receive during the study. Has an open sore(s) that may come in contact with the Valeda System, has periorbital skin erythema or is prone to such conditions with exposure to light. In the opinion of the Investigator, is unlikely to comply with the study protocol.
Study: Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis in Patients With nAMD (XPLORE)
ClinicalTrials.gov Identifier: NCT03805100
Sponsor: Xbrane Biopharma AB; Stada Arzneimittel AG
Design: Randomized, parallel assignment, double masked
Number of Patients: 580
Inclusion Criteria: Written and signed informed consent form obtained at screening, before any study-related procedures. Willingness and ability to undertake all scheduled visits and assessments as judged by the investigator. Newly diagnosed, active subfoveal Choroidal Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye. Note: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography (FA) and intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT) which must be confirmed by the central reading center during Screening: The area of CNV must be ≥50% of the total lesion area in the study eye, and total lesion area ≤9.0 Disc Areas (DA) in size (including blood, scars, and neovascularization) as assessed by FA in the study eye. Best Corrected Visual Acuity (BCVA) of ≤73 and ≥49 ETDRS letter score in the study eye, using ETDRS chart (20/40 to 20/100 Snellen equivalent) at Screening. Fellow eye should not be expected to need any anti-VEGF treatment for the duration of study participation. Age ≥50 years at screening. Male and female subjects of childbearing potential must be willing to completely abstain or agree to use an appropriate method of contraception, from the time of signing informed consent and for the duration of study participation through 3 months, following the last dose of study drug.
Exclusion Criteria: Any previous intervention including pharmacological treatment, laser and/or surgery for wAMD in either eye; (exception: vitamin supplementation for AMD prevention). Any previous vitreoretinal surgery in the study eye for any cause. Any previous IVT treatment including any anti-VEGF medications, steroids and/or any other investigational medication in either eye. The use of long-acting steroids, either systemic or intraocular in any eye, in the 18 months before planned initiation of study treatment. (Note: Iluvien [fluocinolone acetonide intravitreal], current or planned implantation during the study, is prohibited.) Subfoveal fibrosis, atrophy or scarring extending >50% of total lesion area, in the study eye as assessed by the investigator at screening and confirmed by the central reading center prior to randomization. Choroidal neovascularization in either eye due to non-AMD causes (eg, DME, RVO, ocular histoplasmosis or trauma, etc.) as assessed by FA and confirmed by central reading center. Active or recent (within 28 days prior to randomization) intraocular, extraocular, and periocular inflammation or infection in either eye. History of idiopathic or autoimmune-associated uveitis in either eye. Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye. Unmedicated intraocular pressure (IOP) ≥30 mmHg at Screening in either eye. Topical ocular corticosteroids administered for ≥30 consecutive days in the study eye within 90 days prior to Screening. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia. Corneal transplant or corneal dystrophy in the study eye. History of rhegmatogenous retinal detachment in the study eye. History of macular hole in the study eye. Retinal pigment epithelial tear or rip, involving the macula in the study eye as assessed by FA and confirmed by the central reading center. Current vitreous hemorrhage in the study eye. Subretinal hemorrhage that is ≥50% of the total lesion area in the study eye, or if the subretinal hemorrhage involves the fovea is 1 or more DA (≥2.54 mm2) in size in the study eye, as assessed by FA and confirmed by the central reading center. Other intraocular surgery (including cataract surgery) in the study eye within the 3 months prior to baseline. The yttrium aluminum garnet [YAG] posterior capsulotomy is allowed not later than 4 weeks prior to screening. Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity. Significant media opacities (including cataract) in the study eye interfering with BCVA assessment or fundus imaging (FA/FP/OCT). Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation. Presence of advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual field in the study eye (as judged by the investigator). History of glaucoma filtering surgery or argon laser trabeculoplasty in the study eye (Exception: Laser iridotomy and selective laser trabeculoplasty are allowed). Uncontrolled ocular glaucoma or hypertension in the study eye, defined as IOP ≥25 mmHg despite treatment with anti-glaucoma medication. Any previous systemic anti-VEGF treatment (eg, bevacizumab). Contraindication for Lucentis (hypersensitivity to ranibizumab or to any of the study treatment excipients). Current treatment for active systemic infection. Females who are pregnant, nursing, planning a pregnancy during the study, or of childbearing potential and not using a reliable method of contraception and/or not willing to use a reliable method of contraception during their participation in the study. Participation in another clinical trial within the previous 3 months or any other clinical trial of anti-angiogenic drugs. Reasonable suspicion of other disease or condition that might render the subject at a high risk of treatment complications or otherwise confound interpretation of the study results (as judged by the investigator). PK subgroup only: Contraindication for additional blood sampling (as judged by the investigator).
Study: A Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of 1.0 Mg Luminate (Alg-1001) As A Treatment for Non-Exudative Macular Degeneration
ClinicalTrials.gov Identifier: NCT03626636
Sponsor: Allegro Ophthalmics, LLC
Purpose: To evaluate the safety and exploratory efficacy of 1.0 mg of Luminate in patients with intermediate nonexudative macular degeneration.
Design: Randomized, double masked
Number of Patients: 40
Inclusion Criteria: Male or female patients, 50 to 85 years of age at screening visit; subject has signed the informed consent form; subjects with non-exudative AMD having ETDRS BCVA between 33 and 72 letters read (equivalent to 20/40 - 20/200 on Snellen chart) with the level of vision caused by the non-exudative AMD and no other factor/s; subjects with symptomatic decrease in visual acuity in the last 12 months; Subjects with combination of areas of RPE disturbances (hyper or hypopigmentation) and/or >1 large druse(n) (>125 microns) and/or multiple intermediate drusen (62-124 microns) in the macula as confirmed by the central reading center; subjects with evidence of reasonably well-preserved areas of RPE by clinical examination and well-defined RPE and outer segment ellipsoid line by OCT examination in the central 1 mm of the macula as confirmed by the central reading center. More specifically, reasonable reasonably well- preserved central 1 mm of the macula means: the RPE and outer retinal layers throughout the central 1 mm are intact; no signs of NVAMD such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material; no serous pigment epithelium detachments >100 microns in height.
Exclusion Criteria: Females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and/or not willing to maintain a reliable method of contraception during their participation in the study. Women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug. Participation in an investigational drug or device study within 90 days of screening; subjects with active exudative AMD in the fellow eye; subjects who had anti-VEGF IVT in either eye in the past 90 days; subjects with pigment epithelium detachments; subjects with active exudative AMD; subjects with any prior retina surgery; subjects with pathology that could prevent observation and follow-up of macular structures and measurement of BCVA (ie, advanced primary open angle glaucoma, any stage of normal tension glaucoma and corneal opacification); subjects that are likely to require cataract surgery in the opinion of the investigator within the study protocol period.
Study: Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02286089
Sponsor: Cell Cure Neurosciences Ltd.
Purpose: The main objective of the study is evaluation of the safety and tolerability of OpRegen - human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.
Design: No masking, single group
Number of Patients: 24
Inclusion Criteria: Age 50 and older; Diagnosis of dry (non-neovascular) age related macular degeneration in both eyes; Funduscopic findings of dry AMD with progressive geographic atrophy in the macula; Best corrected central visual acuity equal or less than 20/200 in cohorts 1-3 and 20/64-20/250 in cohort 4 in the study eye by ETDRS vision testing; Vision in the non-operated eye must be better than or equal to that in the operated eye; Subjects with sufficiently good health to allow participation in all study-related procedures and complete the study follow-up period (medical records); Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care; Blood counts, blood chemistry, coagulation and urinalysis without abnormal significance; Negative for TB (cohort 4), HIV, HBC, and HCV, negative for CMV IgM and EBV IgM; Patients with no history of malignancy (other than a non-melanoma skin cancer). For cancers in remission for more than 5 years enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment; Willing to defer all future blood and tissue donation; Able to understand and willing to sign informed consent.
Exclusion Criteria: Evidence of neovascular AMD by history, as well as by clinical exam, fluorescein angiography (FA), or ocular coherence tomography (OCT) at baseline in either eye; History or presence of diabetic retinopathy, vascular occlusions, uveitis, Coat's disease, glaucoma, cataract or media opacity preventing posterior pole visualization or any significant ocular disease other than AMD that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; History of retinal detachment repair in the study eye; Axial myopia greater than -6 diopters; At least 2 months following cataract removal in the study eye and Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks and any other ocular surgery in the study eye in the past 3 months prior to implantation; History of cognitive impairments or dementia; Contraindication for systemic immunosuppression; History of any condition other than AMD associated with choroidal neovascularization in the study eye (eg, pathologic myopia or presumed ocular histoplasmosis); Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. Female; pregnancy or breastfeeding; Current participation in another clinical study. Past participation (within 6 months) in any clinical study of a drug administered systemically or to the eye. Currently receiving aspirin, aspirin containing products and/or any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery; History of cancer (other than a non-melanoma skin cancer). For cancers cured more than 5 years ago, enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment.
Study: Alpha MSH in Ocular Disease
ClinicalTrials.gov Identifier: NCT03451578
Sponsor: Duke University
Purpose: The purpose of this study is gaining a better understanding of a molecule called alpha melanocyte stimulating hormone (alpha MSH) and its potential role in your retinal disease. Alpha MSH has been shown to have an important role in the regulation of ocular immunity in animal models of inflammatory retinal diseases and retinal dystrophies, and there may be a protective effect of alpha MSH. By studying the levels of alpha MSH in your eye, we may better understand its role in advanced dry macular degeneration. By studying the levels of this molecule, we hope to better understand if it may be a good target for future treatment.
Design: Single group, no masking, diagnostic
Number of Patients: 60
Inclusion Criteria: 60 years or older; diagnosis of advanced dry macular degeneration with foveal geographic atrophy; limited vision or blindness (20/100 or worse) in that eye; pseudophakia (prior cataract surgery in that eye).
Study: Zimura in Subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02686658
Sponsor: Ophthotech Corporation
Purpose: The objectives of this study are to evaluate the safety and efficacy of intravitreous administration of Zimura when administered in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 200
Inclusion Criteria: Subjects of either gender aged ≥50 years; diagnosis of Non-foveal GA secondary to dry AMD.
Exclusion Criteria: Evidence of choroidal neovascularization (CNV); GA secondary to any condition other than AMD; any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals; any intraocular surgery or thermal laser within 3 months of trial entry; any prior thermal laser in the macular region, regardless of indication; any ocular or periocular infection in the 12 weeks; previous therapeutic radiation in the region of the study eye; any sign of diabetic retinopathy in either eye.
Study: Study of Subretinal Implantation of Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry AMD
ClinicalTrials.gov Identifier: NCT02590692
Sponsor: Regenerative Patch Technologies, LLC
Purpose: The phase 1/2a clinical trial is designed to assess the feasibility of delivery and safety of human embryonic stem cell-derived RPE cells on a parylene membrane (CPCB-RPE1) in patients with advanced, dry age-related macular degeneration.
Design: Single Group Assignment, Open
Number of Patients: 20
Inclusion Criteria: Patients able to understand and willing to sign the informed consent. Adult male or female patients with the age of 55 to 85 (inclusive) years who are not employees of the trial sites; in sufficiently good health to reasonably expect survival for at least 5 years after treatment; clinical findings consistent with advanced dry AMD with evidence of 1 or more areas of ≥1.25 square millimeter of geographic atrophy involving the central fovea; geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF; the best-corrected visual acuity (BCVA) of the eye to receive the implant will be equal or worse than 20/200 in the first half of the study patients and between 20/80 and 20/400 (inclusive) in the second half of the patients. The BCVA of the eye that is NOT to receive the implant will be better or equal to the eye that will receive the implant; medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position postoperatively and use postoperative medications as required; medically suitable for general anesthesia or monitored intravenous sedation, if needed; patients who are pseudophakic or aphakic in the study eye; if designated as an organ donor, willing to forego live organ donation; willing to consent to the postmortem removal of the implant from the treated eye for the sponsor's analysis. The patient may also elect to donate the implanted and fellow, untreated eye, for histological analysis; able to understand the requirements of the study and willing and able to participate in long-term follow-up.
Exclusion Criteria: Presence of active or inactive choroidal neovascularization (CNV); presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serous choroidopathy or any other inflammatory ocular disease except dry eye syndrome; presence or history of severe, end-stage corneal dystrophy; history of steroid induced ocular hypertension or glaucoma; presence of moderate to severe glaucomatous optic neuropathy in the study eye, uncontrolled IOP, use of 2 or more topical agents to control intraocular pressure; history of glaucoma-filtering surgery; presence of moderate to severe nonproliferative diabetic retinopathy in the study eye; presence of any proliferative diabetic retinopathy in the study eye; presence of uncontrolled diabetes mellitus (HbA1c >8) at the time of screening; history of retinal detachment or retinal detachment repair in the study eye other than peripheral retinal tears or holes treated exclusively with laser or cryotherapy; presence of any other sight-threatening ocular disease; history of cognitive impairments or dementia which may impact the patient's ability to participate in the informed consent process and to appropriately complete evaluations; history of any immunodeficiency; evidence of herpetic or other viral eye disease; any current use of immunosuppressive therapy other than intermittent or low dose corticosteroids; participation within previous 3 months in any clinical trial of a drug by ocular or systemic administration (within previous 18 months for sustained release products); axial myopia of greater than -8 diopters in the eye that is to be implanted; axial length greater than 28 mm in the eye that is to be implanted; history of malignancy within the past 5 years (with the exception of successfully treated [excised] basal cell carcinoma [skin cancer] or successfully treated squamous cell carcinoma of the skin); history of myocardial infarction in previous 12 months; alanine transaminase/aspartate aminotransferase (ALT/AST) >3.0 times the upper limit of normal or any known liver disease; renal insufficiency, as defined by estimated creatinine clearance of <45 mL/min; a positive (or "reactive") test for HIV, or Hepatitis B, or Hepatitis C. A hemoglobin concentration of less than 10 gm/dL, a platelet count of less than 100K/µL or an absolute neutrophil count of less than 1000/µL at study entry; ocular lens removal within the previous 6 weeks in either eye; any other ocular surgery in the study eye in the previous 3 months; if female, pregnancy, the wish to become pregnant, or lactation; any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
Study: TOGA: Clinical Study to Evaluate Treatment with ORACEA for Geographic Atrophy
ClinicalTrials.gov Identifier: NCT01782989
Sponsor: Paul Yates, MD, PhD/MEDARVA
Purpose: To evaluate the efficacy and safety of ORACEA in the treatment of geographic atrophy due to dry age-related macular degeneration.
Design: Randomized, Parallel Assignment, Double-Blind, Treatment
Number of Patients: 286
Inclusion Criteria: Best-corrected visual acuity of 20/20 to 20/400 in the study eye; best-corrected visual acuity of hand motion or better in the nonstudy eye; clinical diagnosis of geographic atrophy secondary to nonexudative age-related macular degeneration in at least 1 eye (study eye); geographic atrophy lesions of ≥0.5 and ≤7.0 MPS disc areas.
Exclusion Criteria: History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye; history of or active presence of choroidal neovascularization secondary to exudative AMD in the nonstudy eye requiring any treatment within 12 months prior to day 0.
Study: Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With AMD
ClinicalTrials.gov Identifier: NCT02564978
Sponsor: National Eye Institute
Purpose: To see if minocycline is safe for people with GA and if it helps preserve their vision.
Design: Single Group Assignment, No Masking, Treatment
Number of Patients: 60
Inclusion Criteria: Participant must be 55 years or older; must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes; participant must be able to swallow capsules.
Exclusion Criteria: Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (eg, ethambutol, chloroquine, or hydroxychloroquine); participant has a condition that would preclude participation in the study.
Study: METforMIN: Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD
ClinicalTrials.gov Identifier: NCT02684578
Sponsor: University of California, San Francisco
Purpose: To determine whether metformin, an FDA-approved drug for the treatment of type II diabetes, is a safe and effective treatment to decrease the progression of geographic atrophy in nondiabetic patients with age-related macular degeneration.
Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-Blind, Treatment
Number of Patients: 186
Inclusion Criteria: Subject must have evidence of advanced dry AMD, defined by the characteristic presence of drusen and/or pigmentary changes, as well as geographic atrophy; subject must have clear ocular media and adequate pupillary dilation; study eye must have best corrected visual acuity (BCVA) of 20/20-20/400.
Exclusion Criteria: Subjects with insufficient baseline size of geographic atrophy, less than 1.25 mm2 (0.5 Macular Photocoagulation Study Disc Areas). GA is defined as 1 or more well-defined and often circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The GA in the study eye must be able to be photographed in its entirety, and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements. Information: email@example.com