Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy (AL)
Radiation Retinopathy, Visual Impairment
About this trial
This is an interventional prevention trial for Radiation Retinopathy focused on measuring Visual Acuity, Radiation retinopathy, Faricima, Fluocinolone Acetonide
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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
No Intervention
Intravitreal faricimab
Fluocinolone Acetonide Intravitreal Implants
Observation
Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial.
Study eyes assigned to receive fluocinolone acetonide intravitreal implant will receive a dose of 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien). The implant is supplied in a sterile single use applicator with a 25-gauge needle