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