Exudative Retinal Detachment and Uveal Melanoma Clinical Trial
Official title:
Dexamethasone Intravitreal Implant for the Management of Exudative Retinal Detachment in Patients With Uveal Melanoma
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | July 2022 |
| Est. primary completion date | June 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | i. Ocular Melanoma Center, Massachusetts Eye and Ear | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Ivana K. Kim |
United States,
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events Related to the Implant | The primary outcome of the study will be to evaluate the safety of the implant. All adverse effects not related to the melanoma or radiation treatment identified by ocular examination, diagnostic tests, and subject reporting will be tabulated. This includes significant vision loss, other sight-threatening events, and unforeseen systemic events. | Throughout 12 month study period | |
| Secondary | Exudative retinal detachment resolution | Will be assessed using spectral domain optical coherence tomography, B-scan ultrasonography, and optos wide-angle color photography. | 6 and 12 months after implant insertion | |
| Secondary | Visual Acuity | Measured with ETDRS chart. | 6 and 12 months after implant insertion | |
| Secondary | Complications | The development of iris neovascularization and neovascular glaucoma. | Throughout 12 month study period. |