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RECRUITING
NCT05844982
PHASE3

Intravitreal 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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2023-11-21

Completion Date

2029-12-26

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

DRUG

Faricimab

6.0 mg intravitreal injection at randomization and every 3 months

DRUG

fluocinolone acetonide

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

Locations (22)

Byers Eye Institute at Stanford University

Palo Alto, California, United States

Retina Consultants

Manchester, Connecticut, United States

Retina Associates of Florida, LLC

Tampa, Florida, United States

Northwestern Memorial Group

Chicago, Illinois, United States

IL Eye and Ear Infirmary-University of Illinois at Chicago

Chicago, Illinois, United States

Midwest Eye Institute

Indianapolis, Indiana, United States

University of Iowa Department of Ophthalmology and Visual Sciences

Iowa City, Iowa, United States

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

Grand Rapids, Michigan, United States

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Retina Research Institute, LLC

St Louis, Missouri, United States

The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine

Celveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Retina-Vitreous Consultants, Inc.

Monroeville, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Pittsburgh Clinical Trial Consortium

Sewickley, Pennsylvania, United States

Retina Consultants of Carolina, PA

Greenville, South Carolina, United States

Tennessee Retina, PC

Nashville, Tennessee, United States

Retina Consultants of Texas, PA

Bellaire, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Texas Retina Associates

Lubbock, Texas, United States

The Board of Regents of the University of Wisconsin System

Madison, Wisconsin, United States