New eye injection shows promise for blinding swelling
NCT ID NCT06664502
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This early-stage study tests a new drug called EYE201, given as three eye injections over 12 weeks, to see if it is safe and can help reduce swelling in the back of the eye. It includes people with three different eye conditions that cause vision loss: branch retinal vein occlusion (BRVO), diabetic macular edema (DME), and wet age-related macular degeneration (NVAMD). The study first checks safety in a small group with BRVO, then compares two different doses in larger groups with DME or NVAMD.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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38 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Abilene, Texas
Abilene, Texas, 79606, United States
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Amarillo, Texas
Amarillo, Texas, 79106, United States
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Arecibo, PR
Arecibo, 00612, Puerto Rico
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Asheville, NC
Asheville, North Carolina, 28803, United States
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Austin, Texas
Austin, Texas, 78705, United States
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Bellaire, TX
Bellaire, Texas, 77401, United States
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Bellaire, Texas
Bellaire, Texas, 77401, United States
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Bloomfield, New Jersey
Bloomfield, New Jersey, 07003, United States
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Dallas, Texas
Dallas, Texas, 75231, United States
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Deerfield Beach, FL
Deerfield Beach, Florida, 33064, United States
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Germantown, Tennessee
Germantown, Tennessee, 38138, United States
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Hagerstown, Maryland
Hagerstown, Maryland, 21740, United States
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Knoxville, TN
Knoxville, Tennessee, 37922, United States
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Lemont, IL
Lemont, Illinois, 60439, United States
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Madison, Mississippi
Madison, Mississippi, 39110, United States
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Modesto, CA
Modesto, California, 95356, United States
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Mountain View, California
Mountain View, California, 94040, United States
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Nashville, Tennessee
Nashville, Tennessee, 37203, United States
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Plano, TX
Plano, Texas, 75075, United States
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Round Rock, TX
Round Rock, Texas, 78681, United States
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Sacramento, CA
Sacramento, California, 95825, United States
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Sacramento, California
Sacramento, California, 95841, United States
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San Antonio, Texas
San Antonio, Texas, 78240, United States
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Scottsdale, Arizona
Scottsdale, Arizona, 85255, United States
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Wake Forest, NC
Wake Forest, North Carolina, 27587, United States
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West Columbia, South Carolina
West Columbia, South Carolina, 29169, United States
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Woodlands, Texas
The Woodlands, Texas, 77384, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- High-Dose eye injection tested against stubborn diabetic swelling
- One eye injection, four targets: GenSci148 tested against retinal swelling
- Can one shot in the eye treat diabetic macular edema?
- Could a pill replace eye injections for diabetic vision loss?
- Can a new eye injection beat the current standard for diabetic vision loss?
- Eye injection aims to tame leading causes of blindness