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New hope: eye injections may stop Radiation-Related blindness

NCT ID NCT05844982

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether two different eye treatments can prevent vision loss in people who have had radiation therapy for a type of eye cancer called uveal melanoma. The study will compare faricimab injections given every 3 months, a fluocinolone acetonide implant placed in the eye, and simple observation. About 600 participants will be followed to see if these treatments help maintain vision over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
faricimab and fluocinolone acetonide
What this could lead to
If successful, this could offer a way to prevent vision loss in people who have had radiation therapy for eye cancer.
What could go wrong
This is a large phase 3 trial, but it is still experimental. The treatments may not prevent vision loss and could have side effects like eye inflammation or increased eye pressure.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Key Inclusion Criteria * Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy * Absence of unrelated cause of visual loss * Baseline visual acuity ≥ 34 letters (20/200 Snellen equivalent or better) * Posterior tumor margin \>0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea) * Posterior tumor margin \>0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc) * Calculated total dose to center of the macula ≥30 Gy Key Exclusion Criteria * Opaque media * Inability to undergo fluorescein angiography * Less than 18 years of age * Prior vitrectomy * Intraocular pressure (IOP) ≥ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline * IOP ≥ 25 mmHg at randomization or increase in IOP ≥ 8 mmHg from baseline to randomization (following steroid challenge

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Associated Retinal Consultants, P.C.

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Byers Eye Institute at Stanford University

    RECRUITING

    Palo Alto, California, 94303, United States

  • Emory Eye Center

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Foundation for Vision Research and Retina Specialists of Michigan, P.C.

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • IL Eye and Ear Infirmary-University of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Massachusetts Eye and Ear

    RECRUITING

    Boston, Massachusetts, 02214, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Midwest Eye Institute

    RECRUITING

    Indianapolis, Indiana, 46290, United States

  • Northwestern Memorial Group

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Pittsburgh Clinical Trial Consortium

    RECRUITING

    Sewickley, Pennsylvania, 15143, United States

  • Retina Associates of Florida, LLC

    RECRUITING

    Tampa, Florida, 33609, United States

  • Retina Consultants

    RECRUITING

    Manchester, Connecticut, 06042, United States

  • Retina Consultants of Carolina, PA

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Retina Consultants of Texas, PA

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Retina Research Institute, LLC

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Retina-Vitreous Consultants, Inc.

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • Southeastern Retina Associates

    RECRUITING

    Hixson, Tennessee, 37343, United States

  • Tennessee Retina, PC

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Retina Associates

    RECRUITING

    Lubbock, Texas, 79424, United States

  • The Board of Regents of the University of Wisconsin System

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine

    RECRUITING

    Celveland, Ohio, 44120, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Iowa Department of Ophthalmology and Visual Sciences

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kentucky Advanced Eye Care

    RECRUITING

    Lexington, Kentucky, 40508, United States

  • Washington University Ophthalmology

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Wills Eye Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

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