Clinical trial NCT04082962: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Exudative Retinal Detachment and Uveal Melanoma
Keywords: Dexamethasone
Uveal Melanoma
Steroid-Implant
Exudative Retinal Detachment
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty patients will be enrolled in this randomized pilot study. Patients will be randomized (1:1) to receive the dexamethasone implant or no treatment. A stratified randomization scheme will be performed, with strata defined by tumor height (\< 5mm and 5mm - \< 10 mm). Patients with newly diagnosed choroidal melanoma meeting specified eligibility criteria will be randomly assigned to receive Ozurdex™ (0.7 mg dexamethasone) or no treatment at the time of their tumor localization (tantalum ring placement) surgery for patients receiving PBI or at the time of plaque removal for those patients receiving plaque radiotherapy.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events Related to the Implant
timeFrame: Throughout 12 month study period
Secondary outcomes:
measure: Exudative retinal detachment resolution
timeFrame: 6 and 12 months after implant insertion
measure: Visual Acuity
timeFrame: 6 and 12 months after implant insertion
measure: Complications
timeFrame: Throughout 12 month study period.
Other outcomes:
Locations:
city: Boston
country: United States
facility: i. Ocular Melanoma Center, Massachusetts Eye and Ear
state: Massachusetts
Study officials:
affiliation: Harvard Medical School, Massachusetts Eye and Ear
name: Ivana K Kim, MD
role: PRINCIPAL_INVESTIGATOR
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