Dexamethasone Implant for Retinal Detachment in Uveal Melanoma
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
This is an investigator-initiated Phase I study of a single dose of an
intravitreally-administered dexamethasone implant (Ozurdex™) in subjects with uveal melanomas
(UM) and exudative retinal detachments (ERD: build-up of fluid under the retina that causes
it to detach) being treated with proton beam radiation (PBI) or plaque radiotherapy. Although
PBI is an effective treatment for UM, ERDs may persist after radiation, leading to vision
loss. Effective treatments for ERD are currently lacking. We are conducting this study to
evaluate whether Ozurdex™ can help resolve ERDs that occur in patients with UM. Ozurdex™ has
been approved by the Food and Drug Administration (FDA) to treat certain ocular conditions
such as macular edema, non-infectious uveitis, and diabetic macular edema but it is not
approved for use in patients with UM and ERD. This study will determine the safety of the
dexamethasone implant and provide preliminary evidence of efficacy in this population.