Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ivana K. Kim
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Tumor thickness <= 10 mm.

• Associated serous retinal detachment extending beyond tumor, > two clockhours in extent.

• Primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy.

Exclusion Criteria:

• Any pre-existing glaucoma.

• History of elevated IOP (> 25 mm Hg).

• History of steroid response glaucoma.

• Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva: active ocular herpes simplex, active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

• Any history of ocular herpes simplex.

• Torn or ruptured posterior lens capsule.

• Known hypersensitivity to any components of the dexamethasone intravitreal implant.

• Women of child-bearing potential: pregnant or planning to become pregnant.