A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy
Jaeb Center for Health Research
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.
Description
The primary objectives are to compare long-term visual acuity outcomes in eyes that receive repeated treatment with faricimab or fluocinolone acetonide intravitreal implants with those observed initially and treated only if macular edema (ME) develops. The secondary objectives are to determine if repeated treatment with faricimab or fluocinolone acetonide intravitreal implants versus observation can prevent or alter the course of ME from radiation retinopathy and to evaluate the natural history of radiation retinopathy with multimodal imaging including widefield color photographs, widefield fl…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugFaricimab
6.0 mg intravitreal injection at randomization and every 3 months
- Drugfluocinolone acetonide
0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months
Locations (22)
- Byers Eye Institute at Stanford UniversityPalo Alto, California
- Retina ConsultantsManchester, Connecticut
- Retina Associates of Florida, LLCTampa, Florida
- Northwestern Memorial GroupChicago, Illinois
- IL Eye and Ear Infirmary-University of Illinois at ChicagoChicago, Illinois
- Midwest Eye InstituteIndianapolis, Indiana