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

• Status: Not yet recruiting
• Trial end date: 2028-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaeb Center for Health Research
• Collaborators: Alimera Sciences; Genentech, Inc.; National Eye Institute (NEI); National Institutes of Health (NIH)
• Treatments: Fluocinolone Acetonide

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