Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy (AL)

May 15, 2026 updated by: Jaeb Center for Health Research

A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy

This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objectives are to compare long-term visual acuity outcomes in eyes that receive repeated treatment with faricimab or fluocinolone acetonide intravitreal implants with those observed initially and treated only if macular edema (ME) develops. The secondary objectives are to determine if repeated treatment with faricimab or fluocinolone acetonide intravitreal implants versus observation can prevent or alter the course of ME from radiation retinopathy and to evaluate the natural history of radiation retinopathy with multimodal imaging including widefield color photographs, widefield fluorescein angiography and OCTA.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Byers Eye Institute at Stanford University
        • Contact:
    • Connecticut
      • Manchester, Connecticut, United States, 06042
        • Recruiting
        • Retina Consultants
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Retina Associates of Florida, LLC
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Eye Center
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • IL Eye and Ear Infirmary-University of Illinois at Chicago
        • Contact:
          • Michael J. Heiferman, MD
          • Phone Number: (312) 355-3743
          • Email: annaong@uic.edu
      • Chicago, Illinois, United States, 60611
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Recruiting
        • Midwest Eye Institute
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Department of Ophthalmology and Visual Sciences
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Foundation for Vision Research and Retina Specialists of Michigan, P.C.
        • Contact:
        • Contact:
          • Phone Number: 616-954-2020
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Associated Retinal Consultants, P.C.
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Retina Research Institute, LLC
        • Contact:
    • Ohio
      • Celveland, Ohio, United States, 44120
        • Recruiting
        • The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • Retina-Vitreous Consultants, Inc.
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Wills Eye Hospital
        • Contact:
      • Sewickley, Pennsylvania, United States, 15143
        • Recruiting
        • Pittsburgh Clinical Trial Consortium
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29605
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Retina, PC
        • Contact:
    • Texas
      • Bellaire, Texas, United States, 77401
      • Dallas, Texas, United States, 75390
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • Texas Retina Associates
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • The Board of Regents of the University of Wisconsin System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Active Comparator: Intravitreal faricimab
Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial.
Drug: Faricimab
6.0 mg intravitreal injection at randomization and every 3 months
Active Comparator: Fluocinolone Acetonide Intravitreal Implants
Study eyes assigned to receive fluocinolone acetonide intravitreal implant will receive a dose of 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien). The implant is supplied in a sterile single use applicator with a 25-gauge needle
Drug: fluocinolone acetonide
0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity from baseline
Time Frame: from baseline at 3 years
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
from baseline at 3 years
Loss of 15 or more letters of visual acuity from baseline
Time Frame: from baseline at 3 years
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
from baseline at 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

National Eye Institute (NEI)
Genentech, Inc.
National Institutes of Health (NIH)
Alimera Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2023

Primary Completion (Estimated)

December 26, 2029

Study Completion (Estimated)

December 26, 2029

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol AL
  • UG1EY014231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Visual Impairment

Clinical Trials on Faricimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe