Status:
COMPLETED
Dexamethasone Implant for Retinal Detachment in Uveal Melanoma
Lead Sponsor:
Ivana K. Kim
Conditions:
Exudative Retinal Detachment and Uveal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 detachme...
Detailed Description
Study Objective: The primary objective of the study will be to determine the safety of the Ozurdex (dexamethasone) intravitreal implant. The secondary objective is to determine if the implant helps to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04082962
Start Date
December 11 2018
End Date
December 7 2023
Last Update
December 17 2025
Active Locations (1)
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1
Anne Marie Lane
Boston, Massachusetts, United States, 02114