Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
AL
A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy
2 other identifiers
interventional
600
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 26, 2029
January 29, 2026
September 1, 2025
6.1 years
April 25, 2023
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in visual acuity from baseline
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.
from baseline at 3 years
Loss of 15 or more letters of visual acuity from baseline
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.
from baseline at 3 years
Study Arms (3)
Intravitreal faricimab
ACTIVE COMPARATORStudy 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
ACTIVE COMPARATORStudy 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
Observation
NO INTERVENTIONInterventions
6.0 mg intravitreal injection at randomization and every 3 months
0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Eye Institute (NEI)collaborator
- Genentech, Inc.collaborator
- Jaeb Center for Health Researchlead
- Alimera Sciencescollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (22)
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
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
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2023
First Posted
May 6, 2023
Study Start
November 21, 2023
Primary Completion (Estimated)
December 26, 2029
Study Completion (Estimated)
December 26, 2029
Last Updated
January 29, 2026
Record last verified: 2025-09