Recruiting

Phase 3

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

Sponsor:

Jaeb Center for Health Research

Code:

NCT05844982

Conditions

Radiation Retinopathy

Visual Impairment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Faricimab

fluocinolone acetonide

Study Details

Brief summary:

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.

Conditions

Radiation Retinopathy

Visual Impairment

Study ID

NCT05844982

Start date

Nov 21, 2023

Status verified date

Sep, 2025

Completion date

Dec 26, 2029

Anticipated

Primary completion date

Dec 26, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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

no intervention: Observation

Interventions

Faricimab

6.0 mg intravitreal injection at randomization and every 3 months

fluocinolone acetonide

0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months

Primary outcome measure

Change in visual acuity from baseline [ Time Frame: from baseline at 3 years ]
Loss of 15 or more letters of visual acuity from baseline [ Time Frame: from baseline at 3 years ]

Central Contacts and Locations

Central contacts

Cynthia Stockdale, MPH

8139758690 DRCRNET@JAEB.ORG

Locations

Byers Eye Institute at Stanford University

Recruiting

Palo Alto, California, United States, 94303

Contacts

Prithvi Mruthyunjaya, MD, MHS

6504988790 moniquenguyen92@stanford.edu

Retina Consultants

Recruiting

Manchester, Connecticut, United States, 06042

Contacts

Noam Rudnick, MD, PhD

2036458430 cdwy@retinact.com

Retina Associates of Florida, LLC

Recruiting

Tampa, Florida, United States, 33609

Contacts

Ivan J. Suner, MD

813-875-6373 retinascs@gmail.com

Emory Eye Center

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Andrew M. Hendrick, MD

4047784261 mafif@emory.edu

Northwestern Memorial Group

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Randy Bowen, MD

312-695-2567 madison.wood@northwestern.edu

IL Eye and Ear Infirmary-University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Michael J. Heiferman, MD

(312) 355-3743 annaong@uic.edu

Midwest Eye Institute

Recruiting

Indianapolis, Indiana, United States, 46290

Contacts

John Minturn

317-817-1414 haydenb@midwesteye.com

University of Iowa Department of Ophthalmology and Visual Sciences

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Elaine M. Binkley, MD

3193563185 mary-m-mccormick@uiowa.edu

University of Kentucky Advanced Eye Care

Recruiting

Lexington, Kentucky, United States, 40508

Contacts

Aditya Bansal

8595623570 evelyn.Gonzalez@uky.edu

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02214

Contacts

Ivana K Kim, MD, MBA

6145733465 Grayson_Hanlon@meei.harvard.edu

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

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Thomas M. Aaberg, Jr, MD

holly@fvr.org

616-954-2020

Associated Retinal Consultants, P.C.

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Adam Weiner

2482889132 dgedvilas@arcpc.net

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Lauren Dalvin, MD

507-538-8119 wernimont.suzanne@mayo.edu

Washington University Ophthalmology

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Kisha Piggott, Md, PhD

314-286-2946 squirin@wustl.edu

Retina Research Institute, LLC

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Bradley T. Smith, MD

314-367-1181 rhonda.weeks@rc-stl.com

The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine

Recruiting

Celveland, Ohio, United States, 44120

Contacts

Arun D. Singh, MD

216-445-9519 shephen@ccf.org

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Alison H. Skalet, MD, PhD

503-494-3055 lundquia@ohsu.edu

Retina-Vitreous Consultants, Inc.

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Robert L. Bergren, MD

412-683-5300 brookea@retinapittsburgh.com

Wills Eye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Sara E. Lally, MD

lisac@shields.md

Pittsburgh Clinical Trial Consortium

Recruiting

Sewickley, Pennsylvania, United States, 15143

Contacts

Pamela P. Rath

4123015326 franco@pghtrials.com

Retina Consultants of Carolina, PA

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Chris S. Bergstrom, MD

864-233-5722 Lfrazier@retina-consultants.com

Southeastern Retina Associates

Recruiting

Hixson, Tennessee, United States, 37343

Contacts

Asghar A. Haider

423-756-1002 kschratter@seretina.com

Tennessee Retina, PC

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

David A. Reichstein, MD

6159836000 apecora@tnretina.com

Retina Consultants of Texas, PA

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Amy C Schefler, MD

713-524-3434 allison.stroh@retinaconsultantstexas.com

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Noy Ashkenazy, MD

214-645-2012 norma.ortegon@utsouthwestern.edu

Texas Retina Associates

Recruiting

Lubbock, Texas, United States, 79424

Contacts

Michel Shami, MD

806-792-0066 lbrannan@texasretina.com

The Board of Regents of the University of Wisconsin System

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Michael M. Altaweel, MD

608-263-7290 kadietzman@wisc.edu

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Aug 20, 2026

Last verified

Sep, 2025

Keywords

Visual Acuity
Radiation retinopathy
Faricima
Fluocinolone Acetonide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2026-08-20.