Study Comparing Intravitreal Faricimab Injections and Fluocinolone Acetonide Implants to Observation for Preventing Vision Loss from Radiation Retinopathy after Plaque Brachytherapy

What this Trial Is About

Researchers are studying the effects of intravitreal faricimab injections and fluocinolone acetonide intravitreal implants compared to observation on long-term vision in patients treated for choroidal melanoma with iodine-125 plaque brachytherapy. This phase 3 randomized controlled trial aims to evaluate which approach better preserves visual acuity and how these treatments might prevent or change the progression of macular edema caused by radiation retinopathy. The study also seeks to understand the natural course of radiation retinopathy using advanced imaging techniques. Participants will be assigned to one of three groups repeated faricimab injections, fluocinolone acetonide intravitreal implants, or observation. Those in the faricimab group will receive 6.0 mg doses at the start and every three months. Participants in the fluocinolone acetonide group will receive a 0.19 mg implant at the start and again at 24 months. The observation group will be monitored and treated only if macular edema develops. The study uses imaging methods like widefield color photos, fluorescein angiography, and OCTA to monitor eye changes. During the trial, participants will have their visual acuity tracked over three years, with researchers measuring changes from baseline and noting any significant vision loss. The study involves regular eye exams and imaging to assess the development or prevention of radiation retinopathy and macular edema. Safety and treatment effects will be closely monitored throughout the study period, which runs until December 2029.

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