NCT04082962

Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

Completed Phase 1 Last updated 17 December 2025

What this trial tests

Phase 1 trial testing Dexamethasone intravitreal implant in Exudative Retinal Detachment and Uveal Melanoma in 10 participants. Completed in 7 December 2023.

Timeline

11 December 2018

Primary endpoint
7 December 2023

7 December 2023

Quick facts

Lead sponsor	Ivana K. Kim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	10
Start date	11 December 2018
Primary completion	7 December 2023
Estimated completion	7 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Dexamethasone intravitreal implant — full drug profile →

Conditions studied

• Exudative Retinal Detachment and Uveal Melanoma — all drugs for Exudative Retinal Detachment and Uveal Melanoma →

Sponsor

Ivana K. Kim

Who can join

18 and older, any sex, with Exudative Retinal Detachment and Uveal Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. PLGA-Based Nanomedicine: History of Advancement and Development in Clinical Applications of Multiple Diseases.
   Alsaab HO, Alharbi FD, Alhibs AS, Alanazi NB, et al · · 2022 · cited 141× · PMID 36559223 · DOI 10.3390/pharmaceutics14122728
2. New Therapeutic Perspectives in the Treatment of Uveal Melanoma: A Systematic Review.
   Toro MD, Gozzo L, Tracia L, Cicciù M, et al · · 2021 · cited 26× · PMID 34680428 · DOI 10.3390/biomedicines9101311
3. Radiotherapy in Uveal Melanoma: A Review of Ocular Complications.
   Banou L, Tsani Z, Arvanitogiannis K, Pavlaki M, et al · · 2023 · cited 24× · PMID 37504330 · DOI 10.3390/curroncol30070470
4. Advances in PLGA-Based Drug Delivery Systems for Glioblastoma Treatment.
   Roy S, Alday D, Cai Q. · · 2025 · cited 1× · PMID 41497188 · DOI 10.2147/ijn.s563730