About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Opaque media
Inability to undergo fluorescein angiography
Less than 18 years of age
Prior vitrectomy
Trial design
Treatments tested in this trial
- Faricimab
- fluocinolone acetonide
Treatment groups
Sponsors and collaborators
Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator
National Institutes of Health (NIH)
Collaborator
Alimera Sciences
Collaborator
Genentech, Inc.
Collaborator