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NCT05844982PHASE3Recruiting

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

Jaeb Center for Health Research

Start Date

11/21/2023

Completion Date

12/26/2029

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Faricimab

DRUG

fluocinolone acetonide

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Conditions

Radiation RetinopathyVisual Impairment

Locations

Byers Eye Institute at Stanford University

Palo Alto, California 94303

United States

Retina Consultants

Manchester, Connecticut 06042

United States

Retina Associates of Florida, LLC

Tampa, Florida 33609

United States

Emory Eye Center

Atlanta, Georgia 30322

United States

Northwestern Memorial Group

Chicago, Illinois 60611

United States

IL Eye and Ear Infirmary-University of Illinois at Chicago

Chicago, Illinois 60612

United States

Midwest Eye Institute

Indianapolis, Indiana 46290

United States

University of Iowa Department of Ophthalmology and Visual Sciences

Iowa City, Iowa 52242

United States

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

Grand Rapids, Michigan 49546

United States

Associated Retinal Consultants, P.C.

Royal Oak, Michigan 48073

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Washington University Ophthalmology

St Louis, Missouri 63110

United States

Retina Research Institute, LLC

St Louis, Missouri 63128

United States

The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine

Celveland, Ohio 44120

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Retina-Vitreous Consultants, Inc.

Monroeville, Pennsylvania 15146

United States

Wills Eye Hospital

Philadelphia, Pennsylvania 19107

United States

Pittsburgh Clinical Trial Consortium

Sewickley, Pennsylvania 15143

United States

Retina Consultants of Carolina, PA

Greenville, South Carolina 29605

United States

Southeastern Retina Associates

Hixson, Tennessee 37343

United States

Tennessee Retina, PC

Nashville, Tennessee 37203

United States

Retina Consultants of Texas, PA

Bellaire, Texas 77401

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Texas Retina Associates

Lubbock, Texas 79424

United States

The Board of Regents of the University of Wisconsin System

Madison, Wisconsin 53705

United States