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Current Research on Diabetic Macular Edema

DIABETIC MACULAR EDEMA

Study: This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) Compared with Intravitreal Ranibizumab (Pagoda)

ClinicalTrials.gov Identifier: NCT04108156

Sponsor: Hoffmann-La Roche

Purpose: This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS in participants with diabetic macular edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).

Design: Randomized, parallel assignment, single masking

Number of Patients: 545

Inclusion Criteria: Age ≥18 years at time of signing Informed Consent Form. Documented diagnosis of diabetes mellitus (Type 1 or Type 2). HbA1c level of ≤10% within 2 months prior to screening or at screening. Study eye: Macular thickening secondary to DME involving the center of the fovea with CST ≥325 um on SD-OCT at screening. BCVA of ≥25 letters.

Exclusion Criteria: High-risk proliferative diabetic retinopathy. Active intraocular inflammation (grade trace or above). Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis of either eye. Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study. Cerebrovascular accident or myocardial infarction within 6 months prior to randomization. Atrial fibrillation diagnosis or worsening within 6 months prior to randomization. Uncontrolled blood pressure.

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

Study: Efficacy and Safety of Brolucizumab vs Aflibercept in Patients with Visual Impairment Due to Diabetic Macular Edema (DME)

ClinicalTrials.gov Identifier: NCT03917472

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to DME.

Design: Randomized, parallel assignment, triple masking

Number of Patients: 500

Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening. Study eye: Visual impairment due to DME with: Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT).

Exclusion Criteria: High-risk proliferative diabetic retinopathy (PDR) in the study eye. Concomitant conditions or ocular disorders in the study eye which confound interpretation of study results, compromise visual acuity or require medical or surgical intervention. Any active intraocular or periocular infection or active intraocular inflammation in the either eye. Uncontrolled glaucoma in the study eye. Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200. Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline. Use of intraocular or periocular corticosteroids in the study eye during the 6-month period prior to baseline and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline. Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline.

Information: novartis.email@novartis.com

Study: The Study to YD312 Tablet in Patients with Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT03635814

Sponsor: YD Global Life Science Co., Ltd.

Purpose: This study objectives is to evaluate the efficacy of YD312 to improve visual acuity in patients with diabetic macular edema (DME) compared to placebo and determine optimal dose of phase 2b study.

Design: Randomized, parallel assignment

Number of Patients: 100

Inclusion Criteria: Subject who is male or female ≥19 years of age. Subject who has a diagnosis of Type 1 or 2 diabetes. Subject who has study eye with definite retinal thickening due to diabetic macular edema involving the center of the macula. Subject who has voluntarily signed an informed consent form. Randomization Inclusion Criteria: Study eye must be eligible for the following criteria at randomization: Subject who has study eye with central subfield thickness (CST) of ≥300 μm on optical coherence tomography (OCT). Subject who has study eye with an early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) letter score ranging from 39 to 78, inclusive (approximate Snellen equivalent of 20/32 - 20/160).

Exclusion Criteria: Subject who has study eye with any of the following criteria: Subject whose primary cause of macular edema is non-diabetic disease/condition (eg, cataract extraction, vitreomacular interface abnormalities). Subject who is expected to have no improvement of decreased visual acuity in the opinion of investigator, even if macular edema is resolved (eg, foveal atrophy, abnormal pigmentation, dense subfoveal hard exudate). Subject who has proliferative diabetic retinopathy. Subject who took the following within 3 months before randomization: Focal/grid laser photocoagulation, Intravitreal/circumbulbar corticosteroid, anti-VEGF and pro-VEGF (but, no wash-out period is required for the corticosteroid eyedrops). Subject who took panretinal photocoagulation (PRP) or intravitreal dexamethasone implant within 6 months before randomization. Subject who has a history of vitrectomy. Subject who took major ophthalmic surgeries (all intraocular surgeries including cataract extraction and scleral buckle) within 6 months before randomization. Subject who had systemic treatment of corticosteroid or anti-VEGF within 3 months before randomization. Subject who administered vaccinium myrtillus extract or dobesilate calcium within 2 weeks before randomization. Subject who is suspected to require administration/treatment of drug/procedure that may affect the efficacy evaluation before the participation of clinical trial or during clinical trial (refer to '10.4 Combination Therapy and Contraindication'). Subject who has the following illness or abnormal laboratory test values: Subject who has a hypersensitivity to any excipients of the investigational product or similar class of drug and ingredient. Subject who has uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg). Subject who has uncontrolled diabetes (HbA1c >10.0%). Subject who has uncontrolled glaucoma in either eye (intraocular pressure (IOP) >24 mmHg on medication or according to the investigator's judgment). ANC <1.5 × 109/L. Platelet <125 × 109/L. Total bilirubin >1.5 × ULN. AST or ALT >2 × ULN. Clcr* <40 mL/min. * Clcr (Cockcroft-Gault formula). = [(140 - age) x weight(kg) (x 0.85 for females)] / [72 x serum creatinine (Scr) (mg/dL)]. Severe heart failure (NYHA class III/IV). Malignant tumor within 5 years before randomization. Subject who is known to be HIV positive, is active hepatitis B patient or carrier, or is hepatitis C patient. Ocular inflammatory diseases such as uveitis, conjunctivitis, and blepharitis in either eye. However, the participation of subject in this study is considered at the discretion of investigator. Unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening. Pregnant woman, lactating woman, or female or male subject of childbearing potential. *hormonal contraceptives, intrauterine contraceptive device, sterilization of spouse (eg, vasectomy, tubal ligation), double-barrier method (eg, combinational use of spermicides and condoms, diaphragm, contraceptive sponge, of FemCap). Subject who took administration/procedure of other investigational products or medical devices within longer period between 30 days before screening or over 5time half-life. Subject, at the discretion of the investigator, who is unsuitable to participate in the study.

Study: A Depot Formulation of Sunitinib Malate (GB-102) in Subjects with Diabetic Macular Edema and Retinal Vein Occlusion

ClinicalTrials.gov Identifier: NCT04085341

Sponsor: Graybug Vision

Purpose: Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects with diabetic macular edema and retinal vein occlusion.

Design: Nonrandomized, parallel assignment, no masking

Number of Patients: 20

Inclusion Criteria: Males or females ≥21 years of age. Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion 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 31 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.

Information: vsmith@graybug.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 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 Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema

ClinicalTrials.gov Identifier: NCT04005430

Sponsor: Targeted Therapy Technologies, LLC

Purpose: This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.

Design: Single group assignment, no masking

Number of Patients: 3

Inclusion Criteria: Type I or II diabetes; age ≥18 years; visual acuity letter score in study eye <70 and ≥25 letters (approximate Snellen equivalent 20/32 to 20/320); ophthalmoscopic evidence of center-involved DME, within the central subfield (CSF); OCT CSF thickness value (microns): Zeiss Cirrus: ≥290 in women; ≥305 in men; Heidelberg Spectralis: ≥305 in women; ≥320 in men; Previous treatment with laser, anti-VEGF therapy and/or intravitreal steroids; No previous history of glaucoma or steroid-induced intraocular pressure response in either eye.

Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms; Evidence of external ocular infection; History of open-angle glaucoma or intraocular pressure ≥25 mmHg; History of steroid-induced IOP elevation that required IOP-lowering treatment; History of prior herpetic ocular infection; History of intravitreal or periocular corticosteroids within 3 months prior to enrollment; History of macular laser photocoagulation within 4 months prior to enrollment; History of antiangiogenic therapy within 4 weeks prior to enrollment; History of panretinal photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the next 6 months following enrollment; Presence of vitreomacular traction, epiretinal membrane, tractional retinal detachment, vitreous hemorrhage and or any ocular condition that the investigator judges could interfere in the safety and efficacy assessments; No other major non-diabetic pathology, or anticipation of such in the next 6 months following enrollment that in the opinion of the investigator would substantially and adversely affect assessment of safety and toxicity during the study; Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment; Degenerative myopia; Malignant intraocular disease; Inability to understand informed consent, cooperate with testing or return to follow-up visits; Pregnant or lactating women; Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.

Information: Novartis.email@novartis.com

Study: Multiple Dose Safety and Efficacy of LKA651 in Patients with Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT03927690

Sponsor: Novartis Pharmaceuticals

Purpose: To evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME).

Design: Randomized, parallel assignment, quadruple masking

Number of Patients: 90

Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. Male and female patients age 18 to 85 years of age inclusive at screening. Presence of type I or type II diabetes mellitus. The ETDRS letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be ≥34 letters or better (approximate Snellen equivalent of 20/200) at screening. Presence of DME in the study eye, with decrease in vision due to foveal thickening of central macular thickness ≥320 µm in the central subfield, as assessed on SD-OCT and confirmed by the central reading center at screening.

Information: Novartis.email@novartis.com

Study: The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)

ClinicalTrials.gov Identifier: NCT03984110

Sponsor: Texas Retina Associates

Purpose: The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema.

Design: Randomized, single group assignment, no masking

Number of Patients: 50

Inclusion Criteria: Type 1 or 2 diabetic patients; At least 18 years of age, understands the language of the informed consent, and is willing and able to provide written informed consent before any study procedures; Pseudophakic or phakic lens status with intact posterior lens capsule and/or Nd:YAG laser capsulotomy that in the investigator's opinion is not likely to permit dislocation of Ozurdex implant into the anterior chamber; Center-involving DME >300 µm; Baseline BCVA between 20/40 - 20/320; Eyes with intraocular pressure (IOP) ≤21 and / or treatment with <2 topical IOP-lowering medications (eyes with history of previous angle -closure or similar conditions that have been successfully treated with either laser or surgical intervention are allowed as long as the visual fields and optic nerves have been stable for >1 year prior to study entry and the patient has been and can be safely dilated).

Exclusion Criteria: Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. Patients with known hypersensitivity to any components of Eylea or Ozurdex; Patient has suffered from a stroke or transient ischemic attack (TIA) in the last 6 months; Patients using topical anti-inflammatory medication for the duration of the study; Patients with ACIOL (anterior chamber intraocular lens) and rupture of the posterior lens capsule; Prior panretinal photocoagulation or macular laser treatments within 90 days of screening; Previous vitrectomy; Any ocular condition that in the opinion of the investigator would not permit improvement of visual acuity with resolution of DME (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates and/or poor foveal architecture suggestive of photoreceptor loss); Patients with retinal diseases other than diabetes that can affect macular edema; Eyes with a history of advanced glaucoma (optic nerve head change consistent with glaucoma damage and/or glaucomatous visual field loss), uncontrolled ocular hypertension (baseline IOP >21 mmHg despite use of ≥2 topical IOP-lowering medication); Eyes with a history of steroid response (ie, increase of ≥5 mmHg IOP following topical steroid treatment); Female patients who are pregnant or breastfeeding; Patients who are unable to attend scheduled follow-up visits throughout the 24-week study; Any intravitreal anti-VEGF treatment to study eye within 3 months prior to Day 1; Use of systemic steroid, anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment or anticipated use during the study (these drugs are prohibited from use during the study); History of any previous treatment in the study eye with an ocular corticosteroid implant (eg, Iluvien, Ozurdex, Retisert); Has scarring from laser photocoagulation in the study eye that would compromise VA; or scarring or abnormality from other macular condition, in the investigator's medical judgement, would limit VA (such as an epiretinal membrane or macular hole); Has significant media opacity precluding evaluation of retina and vitreous in the study eye. This includes cataract that is felt to be a major contributor to reduced visual acuity and/or likely to undergo surgical repair within 3 months of randomization. Has any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study (eg, infection, uncontrolled elevated blood pressure, cardiovascular disease, poor glycemic control) or put the subject at risk due to study treatment or procedures; Has had a myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 1 month before enrollment.

Information: kduignan@texasretina.com, sarceneaux@texasretina.com

Study: Long Term Safety of Cooling Anesthesia for Intravitreal Injection (COOL-2)

ClinicalTrials.gov Identifier: NCT03956797

Sponsor: Recens Medical, Inc.

Purpose: The purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.

Design: Randomized, sequential assignment, no masking

Number of Patients: 60

Inclusion Criteria: Men and women >18 years old at screening visit. Men and women who are undergoing intravitreal injections in either 1 eye or both eyes with either Lucentis or Eylea as part of their normal standard of care with a 30-gauge needle. Subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit. Subject is willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria: History of presence of scleromalacia; Preexisting conjunctival, episcleral or scleral defects; Less than 18 years of age; Unable to provide informed consent; Has received less than 3 injections in the study eye; Active severe eye disease not controlled with artificial tears and requiring Restasis or other prescription drugs for dry eye. History of Endophthalmitis with intravitreal injection; History of uveitis; History of retinal detachment in either eye; History of vitrectomy; Subjects who received administration of cooling anesthesia as part of the COOL-1 study will not be excluded and are eligible to participate in this study.

Information: arshad.khanani@gmail.com

Study: Cataract DME - Peri vs Intraop

ClinicalTrials.gov Identifier: NCT03920878

Sponsor: Emory University

Purpose: Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Design: Randomized, parallel assignment

Number of Patients: 60

Inclusion Criteria: Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery.

Exclusion Criteria: Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study. Patients with history of vitrectomy. Patients with neovascular glaucoma.

Information: ahendrick@emory.edu

Study: A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema (AE)

ClinicalTrials.gov Identifier: NCT03866473

Sponsor: Jaeb Center for Health Research

Purpose: Randomized clinical trial evaluating the effect of photobiomodulation compared with sham on central subfield thickness (CST) in eyes with central-involved DME and good vision.

Design: Randomized, single group assignment

Number of Patients: 134

Inclusion Criteria: Age ≥18 years; Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: Current regular use of insulin for the treatment of diabetes; Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes; Documented diabetes by American Diabetes Association and/or the World Health Organization criteria; Able and willing to provide informed consent. At least 1 eye meeting the following criteria: Best corrected E-ETDRS visual acuity letter score ≥79 (ie, 20/25 or better); Ophthalmoscopic evidence of central-involved DME, confirmed by CST on spectral domain OCT: Zeiss Cirrus: ≥290µm in women, and ≥305µm in men, Heidelberg Spectralis: ≥305µm in women, and ≥320µm in men; Media clarity, pupillary dilation, and study participant.

Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant. A condition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status that might preclude completion of follow-up). Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months. Participation in an investigational trial that involved treatment within 30 days of randomization with any drug/device that has not received regulatory approval for the indication being studied. Note: study participants cannot participant in another investigational trial that involves treatment with an investigational drug or device while participating in the study. Systolic blood pressure above 180 or diastolic blood pressure above 110. If blood pressure is brought below 180 systolic and 110 diastolic by anti-hypertensive treatment, individual can become eligible. Systemic anti-vascular endothelial growth factor (anti-VEGF) or pro-VEGF treatment within 4 months prior to randomization. These drugs should not be used during the study. For women of child-bearing potential: pregnant or intending to become pregnant within the next 8 months. Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed. Individual is expecting to move out of the area during the 8 months of the study. A participant will be excluded if the study eye meets any of the following criteria: Macular edema is considered to be due to a cause other than DME. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or investigator assessment of OCT suggests that vitreoretinal interface abnormalities (eg, a taut posterior hyaloid or epiretinal membrane) are contributing to the macular edema. An ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition). An ocular condition is present (other than DME) that, in the opinion of the investigator, might affect visual acuity during the course of the study or require intraocular treatment (eg, vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.) Cataract is present that, in the opinion of the investigator, may alter visual acuity during the course of the study. History of major ocular surgery (including cataract, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery anticipated during the study period. Any history of prior laser or other surgical, intravitreal, or peribulbar treatment for DME or DR (such as panretinal photocoagulation, focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, or anti-VEGF) within the prior 12 months. If treatment was given more than 12 months prior, no more than 4 prior intraocular injections. Enrollment will be limited to a maximum of 15 percent of the planned sample size with any history of anti-VEGF treatment and a maximum of 15% with any history of PRP. Anticipated need to treat DME or DR during the study period. History of topical steroid or non-steroidal anti-inflammatory drug treatment within 30 days prior to randomization. History of YAG capsulotomy performed within 2 months prior to randomization. Any history of vitrectomy. Aphakia. Uncontrolled glaucoma.

Information: drcrnet@jaeb.org

Study: Micropulse for Suppression of Diabetic Macular Edema (PULSE)

ClinicalTrials.gov Identifier: NCT03519581

Sponsor: University of California, Davis; IRIDEX Corporation

Purpose: The purpose of this study is to determine if early intervention with micropulse laser treatment in eyes with good visual acuity (20/32 or better) will improve or stabilize vision loss due to the complications of diabetic macular edema.

Design: Randomized, parallel assignment, double masking

Number of Patients: 30

Inclusion Criteria: Age ≥18 years; Type 1 or type 2 diabetes mellitus; Clinical evidence of center-involved DME confirmed on OCT, and defined by OCT; Central Subfield (CSF) thickness at the time of randomization by the following: Zeiss Cirrus: 275μ in women, and 290μ in men; Heidelberg Spectralis: 290μ in women, and 305μ in men; Best corrected visual acuity of 20/32 or better on ETDRS testing.

Exclusion Criteria: Macular edema from causes other than DME; An ocular condition is present such that in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (ie, foveal atrophy, pigment abnormalities, dense hard exudates); An ocular condition is present other than DME which may contribute to macular edema (ie, vein occlusion, ERM, uveitis, RP). Cataract that in the opinion of the investigator may alter visual acuity throughout the course of the study; History of prior laser or other surgical, intravitreal, or peribulbar treatment for DME in the study eye within the prior 6 months. More than 4 prior intraocular injections for treatment of DME at any time; More than 1 prior focal/grid macular photocoagulation session for treatment of DME at any time; History of topical steroid or NSAID treatment within 30 days prior to randomization; History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization. Any history of vitrectomy. History of major ocular surgery (cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. History of YAG capsulotomy performed within 2 months prior to randomization. Aphakia. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.

Information: clwallace@ucdavis.edu

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; non-study eye with VA<20/100. Unwilling or unable to follow or comply with all study related procedures.

Study: Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT02229175

Sponsor: University of California, San Francisco

Purpose: The purpose of this randomized clinical trial is to determine whether subvisible laser in combination with intravitreal bevacizumab is non-inferior compared to current standard of care (intravitreal bevacizumab alone) in achieving favorable outcomes for visual acuity, mean macular thickness, and patient quality of life, and has fewer needed intravitreal bevacizumab injections throughout the course of the 12 month study period.

Design: Randomized, parallel assignment, double masking

Number of Patients: 60

Inclusion Criteria: Inclusion criteria include adults ≥18 years with type 1 or 2 diabetes mellitus with DME secondary to diabetes mellitus involving the center of the macula in the study eye and with a decrease in vision is determined to be primarily the result of DME in the study eye. The study eye must have a BCVA ETDRS letter score of 50 to 24 (20/30 to 20/320) in the study eye. The patient should be on a stable medical diabetic regimen that is not expected to change.

Exclusion Criteria: Patients are excluded if they have had laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1, more than 2 previous macular laser treatments in the study eye, previous use of intraocular or periocular corticosteroids in the study eye within 90 days of Day 1, previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab, or aflibercept) within 45 days of Day 1, active proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR, uncontrolled diabetes mellitus, as defined by HbA1c >12%, or a patient who is functionally monocular, as defined by the clinician or vision worse than 20/400 in the fellow eye even if that eye is otherwise eligible for the study.

Information: stewartj@vision.ucsf.edu; Catherine.Psaras@ucsf.edu

Study: Steroid vs Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification (STAMP)

ClinicalTrials.gov Identifier: NCT03832179

Sponsor: Bay Area Retina Associates

Purpose: The primary objective of this study is to compare the efficacy of antecedent intravitreal anti-vascular endothelial growth factor therapy vs Ozurdex in reducing postcataract surgery related macular edema in patients with pre-existing diabetic macular edema.

Design: Randomized, parallel assignment, no masking

Number of Patients: 32

Inclusion Criteria: Age >18 years of age; diagnosis of diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis); >250 microns central foveal thickness; able and willing to provide informed consent.

Exclusion Criteria: Significant renal disease; a condition that in the opinion of the investigator would preclude participation; participation in another investigational trial within 30 days of randomization; application of focal macular laser within 120 days of enrollment; administration of Iluvien implant within 3 years of enrollment; administration of intravitreal triamcinolone within 3 months of enrollment; administration of any anti-vascular endothelial growth factor agent within 30 days of enrollment; known hypersensitivity to any of the investigational products; blood pressure >180/110; women who are pregnant, lactating, or intend to become pregnant within 1 year of randomization; vulnerable populations- including but not limited to wards of the state, cognitively impaired individuals, prisoners, institutionalized individuals; individual is planning on moving within 6 months of study enrollment; macular edema secondary to cause other than diabetic macular edema; ocular condition that, in the opinion of the investigators, may affect course of macular edema during course of study (vein occlusion, uveitis, etc.); evidence of ocular infections; evidence of uncontrolled glaucoma; known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex.

Information: cluo@bayarearetina.com, fahmed@bayarearetina.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: DME Cohort: Treatment naïve diabetic macular edema. BCVA ETDRS letter score ≤78 and ≥23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye. Central subfield thickness (CST) of ≥300 microns on SD-OCT (Heidelberg Spectralis or equivalent). Decrease in vision in the study eye determined by the investigator to be primarily the result of DME.

Exclusion Criteria: DME Cohort: Initial diagnosis of DME of more than 6 months from screening in the study eye. Hard exudates in the fovea. Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye. Moderate or dense vitreous hemorrhage preventing clear. visualization of the macula or optic disc in the study eye. Fibrovascular proliferation or tractional retinal detachment in the posterior pole in the study eye. If traction is present outside the posterior pole, it should be considered not at risk of increasing and threatening the macula with the use of anti-VEGF injections, in the investigator's judgement.

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

Study: Cooling Anesthesia for Intravitreal Injection (COOL-1)

ClinicalTrials.gov Identifier: NCT03732287

Sponsor: Recens Medical, Inc.

Purpose: The purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection.

Design: Nonrandomized, sequential assignment

Number of Patients: 40

Inclusion Criteria: Men and women >18 years old at screening visit. Men and women who are undergoing intravitreal injections in either one or both eyes with either Lucentis or Eylea as part of their normal standard of care with a 30 gauge needle. Subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit. Subject is willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria: History of presence of scleromalacia; preexisting conjunctival, episcleral or scleral defects; less than 18 years of age; unable to provide informed consent; has received less than 3 injections in the study eye; active severe eye disease not controlled with artificial tears and requiring Restasis or Xiidra drops. History of endophthalmitis with intravitreal injection; history of uveitis; history of retinal detachment in either eye; history of vitrectomy.

Information: arshad.khanani@gmail.com

Study: A Study to Evaluate the Efficacy and Safety of RO6867461 in Participants with Diabetic Macular Edema (RHINE)

ClinicalTrials.gov Identifier: NCT03622593

Sponsor: Hoffman-La Roche

Purpose: This study will evaluate the efficacy, safety, and pharmacokinetics of RO6867461 administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

Number of Patients: 900

Design: Randomized, parallel assignment, triple masking

Inclusion Criteria: Type 1 or type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of less than or equal to (≤) 10%. Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea. Decreased visual acuity attributable primarily to DME. Ability and willingness to undertake all scheduled visits and assessments. For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment.

Exclusion Criteria: Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin within 3 months prior to day 1. Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest. Currently pregnant or breastfeeding, or intend to become pregnant during the study. Treatment with panretinal photocoagulation or macular laser within 3 months prior to day 1 to the study eye. Any intraocular or periocular corticosteroid treatment within the past 6 months prior to day 1 to the study eye. Prior administration of IVT RO6867461 in either eye. Active intraocular or periocular infection or active intraocular inflammation in the study eye. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye. Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye. Other protocol-specified inclusion/exclusion criteria may apply.

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

Study: A Study to Evaluate the Efficacy and Safety of RO6867461 in Participants with Diabetic Macular Edema (YOSEMITE)

ClinicalTrials.gov Identifier: NCT03622580

Sponsor: Hoffman-La Roche

Purpose: This study will evaluate the efficacy, safety, and pharmacokinetics of RO6867461 administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

Number of Patients: 900

Design: Randomized, parallel assignment, triple masking

Inclusion Criteria: Type 1 or type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of less than or equal to (≤) 10%. Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea. Decreased visual acuity attributable primarily to DME. Ability and willingness to undertake all scheduled visits and assessments. For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment.

Exclusion Criteria: Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin within 3 months prior to day 1. Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest. Currently pregnant or breastfeeding, or intend to become pregnant during the study. Treatment with panretinal photocoagulation or macular laser within 3 months prior to day 1 to the study eye. Any intraocular or periocular corticosteroid treatment within the past 6 months prior to day 1 to the study eye. Prior administration of IVT RO6867461 in either eye. Active intraocular or periocular infection or active intraocular inflammation in the study eye. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye. Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye. Other protocol-specified inclusion/exclusion criteria may apply.

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

Study: Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea in Subjects with Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT03610646

Sponsor: Mylan Inc.

Purpose: Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement will be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea.

Number of Patients: 324

Design: Randomized, parallel assignment, triple masking

Inclusion Criteria: Male or female subjects age ≥18 years. Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye. The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator. Subject is able to understand and voluntarily provide written informed consent to participate in the study. If female of childbearing potential, the subject must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline visit, and should not be nursing or planning a pregnancy. If female, subject must be: Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or of childbearing potential and practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing and continuing at least 90 days following the last treatment. Of non-childbearing potential (ie, postmenopausal for at least 1 year). If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control with sexual partner (as described in inclusion criteria #6b of protocol) or abstain from sexual relations during the study period and up to 90 days following the last treatment dose. Subject is willing to comply with the study duration, study visits and study related procedures.

Exclusion Criteria: Subjects with known hypersensitivity to aflibercept or any of the excipients. Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol. Subjects with uncontrolled hypertension defined as systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization. Subjects who have only 1 functional eye, even if the eye met all other study requirements, or who have an ocular condition on the fellow eye with a poorer prognosis than the study eye.

Information: PrasannaC.Ganapathi@mylan.in

Study: Study of Efficacy and Safety of Brolucizumab vs Aflibercept in Patients with Visual Impairment Due to Diabetic Macular Edema (KESTREL)

ClinicalTrials.gov Identifier: NCT03481634

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

Design: Parallel assignment, double masking

Number of Patients: 534

Inclusion Criteria: Written informed consent before any assessment; Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening; Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study

Exclusion Criteria: Active proliferative diabetic retinopathy in the study eye; Active intraocular or periocular infection or active intraocular inflammation in study eye; Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) >25 millimeters mercury (mmHg); Previous treatment with anti-VEGF drugs or investigational drugs in the study eye; Stroke or myocardial infarction during the 6-month period prior to baseline; Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg; Other protocol-specified inclusion/exclusion criteria may apply.

Information: novartis.email@novartis.com

Study: Phase 4 IOP Signals Associated with ILUVIEN (PALADIN)

ClinicalTrials.gov Identifier: NCT02424019

Sponsor: Alimera Sciences

Purpose: The specific objectives include the study of intraocular pressure (IOP) related data in patients who received ILUVIEN and how it relates to the patient's experiences following prior treatment with a course of corticosteroid which did not result in a clinically significant IOP elevation.

Design: Single group, no masking

Number of Patients: 153

Inclusion Criteria: Patients who are eligible for treatment with ILUVIEN based on the prescribing information.

Exclusion Criteria: Patients who are unable to understand and sign the informed consent form.

Study: ROBIN: A Study That Tests BI 1467335 in Patients with Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.

ClinicalTrials.gov Identifier: NCT03238963

Sponsor: Boehringer Ingelheim

Purpose: The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME).

Design: Randomized, parallel assignment, double blind

Number of Patients: 100

Inclusion Criteria: Of legal age (according to local legislation, usually ≥18 years) at screening, male or female patients (women of childbearing potential (WOCBP) must be ready and able to use 2 methods of contraception with at least one of them being a highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly), diagnosis of diabetes mellitus (type 1 or type 2), glycosylated hemoglobin (HbA1c) ≤12% at screening, non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) in the study eye at screening with NPDR level 47 or level 53, as determined by the Central reading center (CRC) by using the DR severity scale (DRSS), best corrected visual acuity ETDRS letter score ≥70 letters in the study eye at screening, media clarity, pupillary dilation and individual cooperation sufficient for adequate retinal examination including fundus photographs and Optical Coherence Tomography (OCT), signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria: Cataract surgery performed within 6 months prior to screening or planned during the trial, or any additional eye disease in the study eye that, in the opinion of the investigator, could compromise or alter visual acuity during the course of the study (eg, vein occlusion, uncontrolled intraocular pressure (IOP) >24 mmHg on optimal medical treatment, glaucoma with visual field loss, uveitis or other ocular inflammatory disease, vitreomacular traction, monocular vision, history of ischemic optic neuropathy, or genetic disorders such as retinitis pigmentosa), active center-involved DME (CI-DME) on clinical examination and Optical Coherence Tomography (OCT) central subfield thickness above 300 μm in the study eye, as measured by Optovue Optical Coherence Tomography (OCT) Heidelberg OCT, anterior segment and vitreous abnormalities in the study eye that would compromise the adequate assessment of the best corrected visual acuity or an adequate examination of the posterior pole, evidence of neovascularization on clinical examination including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization in the study eye, ruled out by gonioscopy (documented in the last 4 weeks before screening or performed at screening), prior panretinal photocoagulation (defined as ≥100 burns placed previously outside of the posterior pole) in the study eye, history of DME or DR treatment with macular laser within 3 months prior to screening, or intraocular injections of medication within 6 months prior to screening, and no more than 4 prior intraocular injections in the study eye at any time in the past, patients treated with Monoamine Oxidase (MAO) inhibitors or drugs that may have potential side effects due to MAO inhibition, current or planned, during the trial, use of medications known to be toxic to the retina, lens or optic nerve, or cause vision loss, patients who must or wish to continue the intake of other restricted medications or any drug considered likely to interfere with the safe conduct of the trial, estimated Glomerular filtration rate (eGFR) <60 mL/min/1.73m2 calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening, or where the investigator expects filtration rate is likely to drop below 60 mL/min/1.73m2 during the trial, alanine transaminase (ALT) or aspartate transaminase (AST) greater than 2.0-fold the upper limit of normal, or total bilirubin >1.5x upper limit of normal, uncontrolled arterial hypertension defined as a single measurement of systolic blood pressure >180 mmHg, or 2 consecutive measurements of systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg on optimal medical regimen at screening. If blood pressure is brought to ≤160/100 mmHg by antihypertensive treatment until randomization, individual can become eligible, Wolff-Parkinson-White Syndrome, baseline QTc >450 ms, family history of long QT, or on medication prolonging QT time at screening or planned initiation during the trial, diagnosis of a serious or unstable systemic or eye disease and other conditions that, in the clinical judgment of the investigator, are likely to interfere with the analyses of safety and efficacy in this study. Patients with an expected life expectancy of less than 2 years are also excluded, active known or suspected chronic or relevant acute infections, such as HIV (human immunodeficiency virus)\viral hepatitis, or tuberculosis. QuantiFERON TB test and HBs Ag test will be performed during screening. Patients with a positive test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active infection, any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix, chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable study participant or unlikely to complete the trial, known hypersensitivity to any component of the trial drug and/or allergy to fluorescein dye, major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned during the trial, eg, hip replacement, currently enrolled in another investigational drug trial, or less than 30 days or 5 times half-life of the investigational drug, whichever is longer, since ending another investigational drug trial from the screening visit in this trial or receiving other investigational treatment(s); patients participating in a purely observational trial will not be excluded, previous randomization in this trial, women who are pregnant, nursing, or who plan to become pregnant while in the trial, any other clinical condition that, in the opinion of the investigator, would jeopardize patient safety while participating in this clinical trial.

Study: A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT03397264

Sponsor: Opthea Limited

Purpose: A 2 part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.

Design: Randomized, parallel assignment, quadruple masking

Number of Patients: 117

Inclusion Criteria: History of diabetic macular edema (DME) ≤1 year; persistent DME despite prior intravitreal anti-VEGF-A therapy with a suboptimal response; 3 or more prior anti-VEGF-A therapy intravitreal injections; EDTRS BCVA score ≤73 and ≥24 letters.

Exclusion Criteria: Ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye; HbA1c ≥12% and/or recent signs of uncontrolled diabetes; any clinically significant disorder or condition or disease (eg, cardiovascular, renal conditions) that would make the participant unsuitable for the study.

Information: info@opthea.com

Study: DRCR.Net Aflibercept vs Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME (DRCR AC)

ClinicalTrials.gov Identifier: NCT03321513

Sponsor: Jaeb Center for Health Research

Purpose: To compare the efficacy of intravitreous aflibercept with intravitreous bevacizumab + deferred aflibercept if needed in eyes with CI DME and moderate vision loss.

Design: Randomized, parallel assignment, double masking

Number of Patients: 260

Inclusion Criteria: Best corrected Electronic-Early Treatment Diabetic Retinopathy Study visual acuity letter score <69 (ie, 20/50 or worse) and ≥24 (ie, 20/320 or better) within 8 days of randomization. On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula. Diabetic macular edema present on optical coherence tomography (OCT) within 8 days of randomization; Zeiss Cirrus central subfield: ≥290µm in women or ≥305µm in men; Heidelberg Spectralis central subfield: ≥305µm in women or ≥320µm in men; investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate fundus photographs.

Exclusion Criteria: Macular edema is considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (eg, a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition). An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (eg, vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.). Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (ie, cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal). History of an anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in the past 12 months or history of any other treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids). Enrollment will be limited to a maximum of 25% of the planned sample size with any history of anti-VEGF treatment for DME. Once this number of eyes has been enrolled, any history of anti-VEGF treatment for DME will be an exclusion criterion. History of pan-retinal photocoagulation within 4 months prior to randomization or anticipated need for pan-retinal photocoagulation in the 6 months following randomization. History of anti-VEGF treatment for a disease other than DME in the past 12 months. History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. History of YAG capsulotomy performed within 2 months prior to randomization. Aphakia. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis. Evidence of uncontrolled glaucoma.

Study: SwapTwo: Treatment of Diabetic Macular Edema with Aflibercept in Subjects Previously Treated with Ranibizumab or Bevacizumab

ClinicalTrials.gov Identifier: NCT02559180

Sponsor: Rishi Singh, MD, Cleveland Clinic Foundation/Regeneron

Purpose: To evaluate the safety and efficacy of treatment of diabetic macular edema with intravitreal aflibercept in subjects previously treated with intravitreal anti-VEGF agents (ranibizumab or bevacizumab).

Design: Single Group, Open Label, Treatment

Number of Patients: 20

Inclusion Criteria: Foveal-involving retinal edema secondary to DME based on investigator review of clinical exam and SD-OCT with central subfield thickness value of 325 microns by Zeiss Cirrus SD-OCT; E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye; history of previous treatment with anti-VEGF with at least 4 injections over the last 6 months.

Exclusion Criteria: Any prior or concomitant therapy with another investigational agent to treat DME in the study eye; prior panretinal photocoagulation in the study eye within the past 3 months; prior intravitreal anti-VEGF therapy in the study eye within 30 days of enrollment; prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study; previous treatment with intravitreal aflibercept injection; significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam.

Information: mcowend@ccf.org, singhr@ccf.org, borera@ccf.org

Study: Anti-VEGF Treatment for Prevention of PDR/DME

ClinicalTrials.gov Identifier: NCT02634333

Sponsor: Jaeb Center for Health Research

Purpose: To determine the efficacy and safety of intravitreous aflibercept injections vs sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications.

Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-Blind, Prevention

Number of Patients: 322

Inclusion Criteria: No evidence of neovascularization on clinical exam including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed); no evidence of neovascularization (NV) on fluorescein angiography within the 7-modified ETDRS fields, confirmed by the central Reading Center prior to randomization. The widest method of imaging available at the site must be used to document whether there is NV present in the periphery; however, presence of NV outside of the 7-modified ETDRS fields on ultrawide field imaging will not be an exclusion provided treatment is not planned; no center-involved diabetic macular edema (CI-DME) on clinical exam and optical coherence tomography (OCT) central subfield thickness must be below the following gender and OCT-machine specific thresholds.

Exclusion Criteria: Exam or photographic evidence of vitreous or preretinal hemorrhage presumed to be from PDR; history of prior vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR; history of prior PRP (defined as ≥100 burns outside of the posterior pole); an ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (eg, retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, vitreomacular traction, etc.).

Information: www.jaeb.org

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