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.
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)
Opaque media
Inability to undergo fluorescein angiography
Less than 18 years of age
Prior vitrectomy
Parallel
Faricimab
Drug6.0 mg intravitreal injection at randomization and every 3 months
fluocinolone acetonide
Drug0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months
Change in visual acuity from baseline
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Loss of 15 or more letters of visual acuity from baseline
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
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Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator
National Institutes of Health (NIH)
Collaborator
Alimera Sciences
Collaborator
Genentech, Inc.
Collaborator
