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Comparing injections and implants for preventing vision loss from radiation retinopathy

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

Phase 3 Interventional Jaeb Center for Health Research · NCT05844982

This study is testing whether injections or implants can help prevent vision loss in people who have had treatment for choroidal melanoma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorJaeb Center for Health Research Academic / other
Drugs / interventionsfaricimab, radiation
Locations22 sites (Palo Alto, California and 21 other locations)
Trial IDNCT05844982 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial evaluates the effectiveness of intravitreal faricimab injections and fluocinolone acetonide implants in preventing long-term visual acuity loss in patients treated for choroidal melanoma with iodine-125 plaque brachytherapy. Participants will be divided into groups receiving either treatment or observation, with the latter only receiving treatment if macular edema develops. The study also aims to assess the natural progression of radiation retinopathy using advanced imaging techniques.

Who should consider this trial

Good fit: Ideal candidates include adults with primary uveal melanoma treated with plaque brachytherapy and a baseline visual acuity of 20/200 or better.

Not a fit: Patients with unrelated causes of visual loss or those who have undergone prior vitrectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve visual outcomes for patients suffering from radiation retinopathy.

How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria

* 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

Key Exclusion Criteria

* 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

Where this trial is running

Palo Alto, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Radiation RetinopathyVisual ImpairmentVisual AcuityRadiation retinopathyFaricimaFluocinolone Acetonide
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.