Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 Mg) Intravitreal Implants Vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
- Conditions
- Radiation RetinopathyVisual Impairment
- Interventions
- Registration Number
- NCT05844982
- Lead Sponsor
- Jaeb Center for Health Research
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravitreal faricimab 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. Fluocinolone Acetonide Intravitreal Implants fluocinolone acetonide 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
- Primary Outcome Measures
Name Time Method Loss of 15 or more letters of visual acuity from baseline 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.
Change in visual acuity from baseline 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Byers Eye Institute at Stanford University
🇺🇸Palo Alto, California, United States
Retina Associates of Florida, LLC
🇺🇸Tampa, Florida, 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
🇺🇸Saint 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
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
Texas Retina Associates
🇺🇸Lubbock, Texas, United States
The Board of Regents of the University of Wisconsin System
🇺🇸Madison, Wisconsin, United States