Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exudative Retinal Detachment and Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone intravitreal implant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Participants receiving dexamethasone implant.
- interventionNames
- Drug: Dexamethasone intravitreal implant
- type
- NO_INTERVENTION
- label
- Non-treatment group (control)
- description
- Participants not receiving dexamethasone implant.
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events Related to the Implant
- timeFrame
- Throughout 12 month study period
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDScotto J, Fraumeni JF Jr, Lee JA. Melanomas of the eye and other noncutaneous sites: epidemiologic aspects. J Natl Cancer Inst. 1976 Mar;56(3):489-91. doi: 10.1093/jnci/56.3.489. PMID 1255781
- BACKGROUNDCollaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: V. Twelve-year mortality rates and prognostic factors: COMS report No. 28. Arch Ophthalmol. 2006 Dec;124(12):1684-93. doi: 10.1001/archopht.124.12.1684. PMID 17159027
- BACKGROUNDGragoudas ES. Proton beam irradiation of uveal melanomas: the first 30 years. The Weisenfeld Lecture. Invest Ophthalmol Vis Sci. 2006 Nov;47(11):4666-73. doi: 10.1167/iovs.06-0659. No abstract available. PMID 17065472
- BACKGROUNDKivela T, Eskelin S, Makitie T, Summanen P. Exudative retinal detachment from malignant uveal melanoma: predictors and prognostic significance. Invest Ophthalmol Vis Sci. 2001 Aug;42(9):2085-93. PMID 11481276
- BACKGROUNDGibran SK, Kapoor KG. Management of exudative retinal detachment in choroidal melanoma. Clin Exp Ophthalmol. 2009 Sep;37(7):654-9. doi: 10.1111/j.1442-9071.2009.02127.x. PMID 19788660
- BACKGROUNDChar DH, Bove R, Phillips TL. Laser and proton radiation to reduce uveal melanoma-associated exudative retinal detachments. Am J Ophthalmol. 2003 Jul;136(1):180-2. PMID 12834689
- BACKGROUNDParrozzani R, Pilotto E, Dario A, Miglionico G, Midena E. Intravitreal triamcinolone versus intravitreal bevacizumab in the treatment of exudative retinal detachment secondary to posterior uveal melanoma. Am J Ophthalmol. 2013 Jan;155(1):127-133.e2. doi: 10.1016/j.ajo.2012.06.026. Epub 2012 Sep 18. PMID 22995029
- Kim IK, Lane AM, Jain P, Awh C, Gragoudas ES. Ranibizumab for the Prevention of Radiation Complications in Patients Treated With Proton Beam Irradiation for Choroidal Melanoma. Trans Am Ophthalmol Soc. 2016 Aug;114:T2.