Comparing injections and implants for preventing vision loss from radiation retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Byers Eye Institute at Stanford University
  Palo Alto, California, United States Recruiting
• Retina Consultants
  Manchester, Connecticut, United States Recruiting
• Retina Associates of Florida, LLC
  Tampa, Florida, United States Recruiting
• Emory Eye Center
  Atlanta, Georgia, United States Recruiting
• Northwestern Memorial Group
  Chicago, Illinois, United States Recruiting
• IL Eye and Ear Infirmary-University of Illinois at Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Cynthia Stockdale, MPH
• Email: DRCRNET@JAEB.ORG
• Phone: 8139758690

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.