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New eye injection shows promise for blinding swelling

NCT ID NCT06664502

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

38 people

The number who actually took part.

Started

Nov 2024

Finished

Aug 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Abilene, Texas

    Abilene, Texas, 79606, United States

  • Amarillo, Texas

    Amarillo, Texas, 79106, United States

  • Arecibo, PR

    Arecibo, 00612, Puerto Rico

  • Asheville, NC

    Asheville, North Carolina, 28803, United States

  • Austin, Texas

    Austin, Texas, 78705, United States

  • Bellaire, TX

    Bellaire, Texas, 77401, United States

  • Bellaire, Texas

    Bellaire, Texas, 77401, United States

  • Bloomfield, New Jersey

    Bloomfield, New Jersey, 07003, United States

  • Dallas, Texas

    Dallas, Texas, 75231, United States

  • Deerfield Beach, FL

    Deerfield Beach, Florida, 33064, United States

  • Germantown, Tennessee

    Germantown, Tennessee, 38138, United States

  • Hagerstown, Maryland

    Hagerstown, Maryland, 21740, United States

  • Knoxville, TN

    Knoxville, Tennessee, 37922, United States

  • Lemont, IL

    Lemont, Illinois, 60439, United States

  • Madison, Mississippi

    Madison, Mississippi, 39110, United States

  • Modesto, CA

    Modesto, California, 95356, United States

  • Mountain View, California

    Mountain View, California, 94040, United States

  • Nashville, Tennessee

    Nashville, Tennessee, 37203, United States

  • Plano, TX

    Plano, Texas, 75075, United States

  • Round Rock, TX

    Round Rock, Texas, 78681, United States

  • Sacramento, CA

    Sacramento, California, 95825, United States

  • Sacramento, California

    Sacramento, California, 95841, United States

  • San Antonio, Texas

    San Antonio, Texas, 78240, United States

  • Scottsdale, Arizona

    Scottsdale, Arizona, 85255, United States

  • Wake Forest, NC

    Wake Forest, North Carolina, 27587, United States

  • West Columbia, South Carolina

    West Columbia, South Carolina, 29169, United States

  • Woodlands, Texas

    The Woodlands, Texas, 77384, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.