Spots Global Cancer Trial Database for Dexamethasone Implant for Retinal Detachment in Uveal Melanoma
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Trial Identification
Brief Title: Dexamethasone Implant for Retinal Detachment in Uveal Melanoma
Official Title: Dexamethasone Intravitreal Implant for the Management of Exudative Retinal Detachment in Patients With Uveal Melanoma
Study ID: NCT04082962
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
i. Ocular Melanoma Center, Massachusetts Eye and Ear, Boston, Massachusetts, United States
Contact Details
Name: Ivana K Kim, MD
Affiliation: Harvard Medical School, Massachusetts Eye and Ear
Role: PRINCIPAL_INVESTIGATOR
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