Faricimab or Fluocinolone Acetonide for Radiation Retinopathy

This study is looking at ways to prevent vision loss from radiation retinopathy, a condition that can affect your vision after treatment for choroidal melanoma (a type of eye cancer). Researchers are comparing two medications, faricimab and fluocinolone acetonide, to simply observing the eye. Faricimab is given as an injection into the eye every three months, and fluocinolone acetonide is a small implant placed in the eye at the start and again after two years. The goal is to see if these treatments can help maintain your vision over three years, specifically by preventing a significant drop in how well you can see. You might be able to join if you are an adult who has received plaque brachytherapy for primary uveal melanoma, have good baseline vision, and your tumor is not too close to the center of your macula (the part of your eye responsible for sharp, central vision). The study is currently unclear on its recruitment status and plans to enroll 600 participants.

Study design
This is a randomized controlled trial, meaning participants will be assigned by chance to receive either faricimab, fluocinolone acetonide, or observation. The study plans to enroll 600 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure changes in your vision for up to 3 years after you start the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05844982

Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy

Recruiting
PHASE3Ages 18+InterventionalPrevention
Jaeb Center for Health Research
~600 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Faricimabfluocinolone acetonide

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in visual acuity from baseline
Measured over from baseline at 3 years
+1 more outcome measured
Radiation Retinopathy
Visual Impairment
27 sites across 19 states
Pennsylvania3
Texas3
Illinois2
Michigan2
Missouri2
Tennessee2
California1
Connecticut1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in visual acuity from baselinefrom 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.

  • Loss of 15 or more letters of visual acuity from baselinefrom 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.