Actively Recruiting
Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants Compared to Observation for Preventing Vision Loss Due to Radiation Retinopathy
Led by Jaeb Center for Health Research · Updated on 2026-05-18
600
Participants Needed
23
Research Sites
N/A
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
Researchers are evaluating the effects of two eye treatments, intravitreal faricimab injections and fluocinolone acetonide intravitreal implants, compared to observation alone, on long-term vision after treating choroidal melanoma with iodine-125 plaque brachytherapy. This trial aims to compare how well these treatments maintain visual acuity and prevent vision loss caused by radiation retinopathy. The study also seeks to understand the natural progression of radiation retinopathy using detailed imaging methods. Participants are divided into three groups: one receiving 6.0 mg faricimab injections every three months, another receiving a 0.19 mg fluocinolone acetonide implant at the start and again at 24 months, and a third group observed without treatment unless macular edema develops. The fluocinolone implant is delivered with a specialized applicator, while faricimab is given via intravitreal injection. Treatment and observation continue with monitoring over time. During the study, participants will have their visual acuity measured at baseline and followed for three years to assess changes and the occurrence of significant vision loss. Researchers will use multimodal imaging techniques such as widefield color photos, fluorescein angiography, and OCT angiography to evaluate eye health and monitor radiation retinopathy progression. Safety and vision outcomes will be closely observed throughout the trial period, which lasts several years.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Primary uveal melanoma (excluding iris melanoma) treated with plaque brachytherapy
- No unrelated causes of vision loss
- Baseline visual acuity of 20/200 Snellen equivalent or better (at least 34 letters)
- Tumor located away from the center of the macula and edge of the optic disc
- Calculated radiation dose to center of the macula of 30 Gy or more
You will not qualify if you...
- Opaque media preventing eye examination
- Unable to undergo fluorescein angiography
- Under 18 years of age
- Prior vitrectomy surgery
- Intraocular pressure of 25 mmHg or higher, or history of steroid-induced high eye pressure requiring treatment
- Increased intraocular pressure of 8 mmHg or more from baseline to randomization after steroid challenge
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive repeated treatment with faricimab injections or fluocinolone acetonide intravitreal implants, or are observed without treatment unless macular edema develops.
Visits every 3 months for faricimab injections; fluocinolone implant administered at randomization and at 24 months; observation group monitored accordingly
Duration - Up to 3 years
Participants are monitored over time to assess long-term vision outcomes and the natural history of radiation retinopathy using multimodal imaging.
Regular monitoring visits throughout the study duration
Trial Site Locations
Total: 23 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
Emory Eye Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Northwestern Memorial Group
Chicago, Illinois, United States, 60611
Actively Recruiting
6
IL Eye and Ear Infirmary-University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
7
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
Actively Recruiting
8
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, United States, 52242
Actively Recruiting
9
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
10
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
Actively Recruiting
11
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
Retina Research Institute, LLC
St Louis, Missouri, United States, 63128
Actively Recruiting
13
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Celveland, Ohio, United States, 44120
Actively Recruiting
14
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
15
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
16
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
17
Pittsburgh Clinical Trial Consortium
Sewickley, Pennsylvania, United States, 15143
Actively Recruiting
18
Retina Consultants of Carolina, PA
Greenville, South Carolina, United States, 29605
Actively Recruiting
19
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203
Actively Recruiting
20
Retina Consultants of Texas, PA
Bellaire, Texas, United States, 77401
Actively Recruiting
21
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
22
Texas Retina Associates
Lubbock, Texas, United States, 79424
Actively Recruiting
23
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
C
Cynthia Stockdale, MPH
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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