Actively Recruiting
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Led by Jaeb Center for Health Research · Updated on 2026-01-29
600
Participants Needed
22
Research Sites
318 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary uveal melanoma (excluding iris melanoma) treated with plaque brachytherapy
- No unrelated causes of vision loss
- Baseline visual acuity of 34 letters or better (20/200 Snellen equivalent or better)
- Tumor's posterior margin is not under the center of the fovea (greater than 0 mm from macula center)
- Tumor's posterior margin is not touching the optic disc (greater than 0 mm from closest disc margin)
- Calculated radiation dose to the center of the macula is 30 Gy or higher
You will not qualify if you...
- Opaque media preventing examination
- Inability to have fluorescein angiography
- Under 18 years of age
- Prior vitrectomy surgery
- Intraocular pressure 25 mmHg or higher or history of steroid-induced eye pressure elevation requiring treatment at baseline
- Intraocular pressure 25 mmHg or higher at randomization or increase of 8 mmHg or more from baseline to randomization following steroid challenge
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Byers Eye Institute at Stanford University
Palo Alto, California, United States, 94303
Actively Recruiting
2
Retina Consultants
Manchester, Connecticut, United States, 06042
Actively Recruiting
3
Retina Associates of Florida, LLC
Tampa, Florida, United States, 33609
Actively Recruiting
4
Northwestern Memorial Group
Chicago, Illinois, United States, 60611
Actively Recruiting
5
IL Eye and Ear Infirmary-University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
6
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
Actively Recruiting
7
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
9
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
Actively Recruiting
10
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Retina Research Institute, LLC
St Louis, Missouri, United States, 63128
Actively Recruiting
12
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Celveland, Ohio, United States, 44120
Actively Recruiting
13
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
14
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
15
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
16
Pittsburgh Clinical Trial Consortium
Sewickley, Pennsylvania, United States, 15143
Actively Recruiting
17
Retina Consultants of Carolina, PA
Greenville, South Carolina, United States, 29605
Actively Recruiting
18
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203
Actively Recruiting
19
Retina Consultants of Texas, PA
Bellaire, Texas, United States, 77401
Actively Recruiting
20
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
21
Texas Retina Associates
Lubbock, Texas, United States, 79424
Actively Recruiting
22
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
C
Cynthia Stockdale, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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