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

August 18, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • University of Kentucky Advanced Eye Care
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02214
    • 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:
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Ophthalmology
        • 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
      • Hixson, Tennessee, United States, 37343
        • Recruiting
        • Southeastern Retina Associates
        • Contact:
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaeb Center for Health Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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