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Faricimab or Fluocinolone for Radiation Retinopathy

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

Recruiting Phase 3 Interventional Study
Radiation Retinopathy Visual Impairment
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
600 (estimated)
Sponsor
Jaeb Center for Health Research · Other
Who this trial is looking for

This trial is looking for adults with a specific eye tumor who have had treatment with brachytherapy. Participants will receive either an injection or an implant to see if it helps preserve their vision.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with primary uveal melanoma.
  • I have had treatment with plaque brachytherapy.
  • I have a visual acuity of 34 letters or better.
  • My tumor is not under the center of my macula.
  • My tumor is not touching the edge of my optic disc.
  • The treatment I had delivered a total dose of at least 30 Gy to my macula.

You may not be able to join if

  • I have cloudy vision that prevents clear examination.
  • I cannot have fluorescein angiography.
  • I am under 18 years old.
  • I have had vitrectomy surgery in the past.
  • My eye pressure is 25 mmHg or higher.
  • I have a history of eye pressure increase from steroids that needed treatment.
  • My eye pressure is 25 mmHg or higher at the start of the trial.
  • My eye pressure increased by 8 mmHg or more from before the trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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 Locations

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Eligibility 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 …
Contacts

Cynthia Stockdale, MPH

8139758690

DRCRNET@JAEB.ORG

CONTACT

NCT ID: NCT05844982 Source: ClinicalTrials.gov