Phase
Condition
Macular Degeneration
Macular Edema
Geographic Atrophy
Treatment
EYE201
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
General Key Inclusion Criteria
Written informed consent before the first study-related activity
Be male or female ≥ 18 years of age
If female, have a negative serum pregnancy test at Screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential.
General Key Exclusion Criteria
Be pregnant or breastfeeding
Have a history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest.
Have had Yttrium-Aluminum Garnet laser capsulotomy in the study eye within 90 days of Screening
Have had Pan-retinal Photocoagulation or focal thermal laser photocoagulation in the study eye
Have tractional retinal detachment in the study eye
Have uncontrolled glaucoma (defined as IOP ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye
BRVO-specific Inclusion Criteria
Participants must:
Be diagnosed with BRVO in the study eye
Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO BRVO-specific Exclusion Criteria
Participants must not:
Have macular edema in the study eye considered to be secondary to a cause other than BRVO (e.g., DME, Irvine-Gass syndrome)
Have active iris or angle neovascularization or neovascular glaucoma in the study eye
Have proliferative retinopathy, central retinal vein occlusion, or hemiretinal vein occlusion
DME-specific Inclusion Criteria
Participants must:
Have Type 1 or Type 2 diabetes mellitus and a glycated hemoglobin A1c (HbA1c) of ≤ 12%
Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of DME
DME-specific Exclusion Criteria
Participants must not:
Have macular edema in the study eye considered to be secondary to a cause other than DME (eg, retinal vein occlusion, Irvine-Gass syndrome)
Have active iris or angle neovascularization or neovascular glaucoma in the study eye
Have high-risk proliferative diabetic retinopathy characteristics in the study eye
NVAMD-specific Inclusion Criteria
Participants must:
Be ≥ 50 years of age
Have a ETDRS BVCA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
Subfoveal CNV secondary to AMD, with a total lesion size (including blood, scar/atrophy & neovascularization) of ≤ 9-disc areas, of which at least 50% must be active CNV in the study eye
Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
Be treatment naïve with vision loss in the study eye secondary to NVAMD diagnosed within 21 days prior to the Day 1 study treatment NVAMD-specific Exclusion Criteria
Participants must not:
Have had previous thermal subfoveal laser therapy in the study eye
Have any subfoveal atrophy or scarring, blood over the fovea, or subfoveal fibrosis in the study eye. Additionally, no more than 25% of the total lesion size may be made up of scarring or atrophy
Have had previous photodynamic therapy with Visudyne in the study eye
Have diabetic retinopathy in the study eye
Study Design
Study Description
Connect with a study center
Arecibo, PR
Arecibo, 00612
Puerto RicoActive - Recruiting
Scottsdale, Arizona
Scottsdale, Arizona 85255
United StatesActive - Recruiting
Modesto, CA
Modesto, California 95356
United StatesActive - Recruiting
Sacramento, CA
Sacramento, California 95825
United StatesActive - Recruiting
Deerfield Beach, FL
Deerfield Beach, Florida 33064
United StatesActive - Recruiting
Germantown, Tennessee
Germantown, Tennessee 38138
United StatesActive - Recruiting
Knoxville, TN
Knoxville, Tennessee 37922
United StatesActive - Recruiting
Amarillo, Texas
Amarillo, Texas 79106
United StatesActive - Recruiting
Austin, Texas
Austin, Texas 78705
United StatesActive - Recruiting
Bellaire, TX
Bellaire, Texas 77401
United StatesActive - Recruiting
Dallas, Texas
Dallas, Texas 75231
United StatesActive - Recruiting
Plano, TX
Plano, Texas 75075
United StatesActive - Recruiting
Round Rock, TX
Round Rock, Texas 78681
United StatesActive - Recruiting
Woodlands, Texas
The Woodlands, Texas 77384
United StatesActive - Recruiting
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