NCT04082962CompletedPhase 1
Dexamethasone Implant for Retinal Detachment in Uveal Melanoma
Dexamethasone Intravitreal Implant for the Management of Exudative Retinal Detachment in Patients With Uveal Melanoma
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 27 Aug 2019
- Start date
- 11 Dec 2018
- Primary completion date
- 7 Dec 2023
- Lead sponsor
- Ivana K. Kim
- Diseases
- Melanoma
- NCT number
- NCT04082962
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 11 Dec 2018 to the primary completion date, 7 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Known hypersensitivity to any components of the dexamethasone intravitreal implant.
Other
- Any pre-existing glaucoma.
- Torn or ruptured posterior lens capsule.
- Women of child-bearing potential: pregnant or planning to become pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anne Marie Lane Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.