Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
NCT ID: NCT05844982
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2023-11-21
2029-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intravitreal 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.
Faricimab
6.0 mg intravitreal injection at randomization and every 3 months
Fluocinolone Acetonide Intravitreal Implants
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
fluocinolone acetonide
0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months
Observation
No interventions assigned to this group
Interventions
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Faricimab
6.0 mg intravitreal injection at randomization and every 3 months
fluocinolone acetonide
0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
National Institutes of Health (NIH)
NIH
Alimera Sciences
INDUSTRY
Genentech, Inc.
INDUSTRY
Jaeb Center for Health Research
OTHER
Responsible Party
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Locations
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Byers Eye Institute at Stanford University
Palo Alto, California, United States
Retina Consultants
Manchester, Connecticut, United States
Retina Associates of Florida, LLC
Tampa, Florida, United States
Northwestern Memorial Group
Chicago, Illinois, 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
St 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
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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Protocol AL
Identifier Type: -
Identifier Source: org_study_id
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