Dexamethasone Implant for Retinal Detachment in Uveal Melanoma
NCT ID: NCT04082962
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2018-12-11
2023-12-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background: This is a single site investigator-initiated Phase I study of a single dose of intravitreally administered dexamethasone implant (Ozurdex™) in subjects with choroidal melanomas and exudative retinal detachments being treated with proton beam irradiation or plaque radiation therapy. This is one of the first studies to evaluate the Ozurdex™ implant in this setting. Therefore the primary goal is to evaluate safety.
Patient Population: Twenty patients will be enrolled in this randomized pilot study. Patients must meet the following eligibility criteria to enroll: Tumor thickness ≤ 10 mm, associated serous retinal detachment \> two clock hours in extent, primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy. Males and females \>18 years of age are eligible.
Methods: 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 will be masked to their treatment assignment.
Patients will be randomly assigned to receive Ozurdex™ (0.7 mg dexamethasone) or no treatment at either (1) the time of their tumor localization (tantalum ring placement) surgery before proton therapy or (2) their surgery removing the plaque following plaque radiotherapy. A sham treatment procedure to maintain the mask will be unnecessary.
Patients will be followed at 6 weeks, 14 weeks, 28 weeks and 54 weeks after administration of the dexamethasone implant. Visual acuity, intraocular pressure, optical coherence tomography, B-scan ultrasonography, wide-angle color photography and full ophthalmological examination will be performed pre-op and on every follow-up visit. Evaluation of adverse events and review of medical history and medication use will be completed at all follow-up visits.
The primary outcome of the study will be to evaluate the safety of the implant. This will be done by monitoring for all adverse effects not related to the melanoma or radiation treatment including significant vision loss, other sight-threatening events, and unforeseen systemic events.
Secondary endpoints include resolution of retinal detachment at 6 and 12 months after implant insertion, visual acuity at 6 and 12 months after implant insertion, and development of iris neovascularization and neovascular glaucoma during the 12 month study period.
Statistical Analysis Plan: There is no formal sample size calculation in a pilot/phase I study. As this is a phase I study, a sample size of 20 patients is chosen, making sure that it is feasible financially and logistically to conduct the study.
Safety Endpoints: Incidence and severity of ocular and systemic adverse events identified by ocular examination, diagnostic tests, and subject reporting will be summarized. Comparisons of these endpoints of study subjects who received treatment may be made with those of control subjects, matched on prognostic factors including tumor size and tumor location. The proportion of treated patients with adverse events will be tabulated by body system, stratified by tumor size and location, and compared to patients in the control arm using Fisher's exact test and other appropriate tests of association.
Efficacy Endpoints: Descriptive statistics will be generated to assess resolution of exudative retinal detachment at 6 months after placement of the Ozurdex implant or no treatment. This is the most important efficacy endpoint. Descriptive statistics will be generated for the following secondary efficacy endpoints: incidence of neovascular glaucoma, incidence of rubeosis, percent of patients with exudative retinal detachment at 12 months, and distribution of visual acuity measures at 6 months and 12 months. All measures will be compared between patients in the treatment arm and those in the control arm of the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Group
Participants receiving dexamethasone implant.
Dexamethasone intravitreal implant
Ozurdex™ is an intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system (NOVADUR™ system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix, which slowly degrades to lactic acid and glycolic acid.). Ozurdex™ is preservative-free. It is supplied in a foil pouch with a single-use plastic applicator.
Non-treatment group (control)
Participants not receiving dexamethasone implant.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexamethasone intravitreal implant
Ozurdex™ is an intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system (NOVADUR™ system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix, which slowly degrades to lactic acid and glycolic acid.). Ozurdex™ is preservative-free. It is supplied in a foil pouch with a single-use plastic applicator.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Associated serous retinal detachment extending beyond tumor, \> two clockhours in extent.
* Primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ivana K. Kim
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ivana K. Kim
Associate Professor of Ophthalmology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ivana K Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School, Massachusetts Eye and Ear
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anne Marie Lane
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Char 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.
Gibran 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.
Scotto 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.
Collaborative 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.
Gragoudas 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.
Kivela 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.
Parrozzani 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.
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.
Malcles A, Nguyen AM, Mathis T, Grange JD, Kodjikian L. Intravitreal dexamethasone implant (Ozurdex(R)) for exudative retinal detachment after proton beam therapy for choroidal melanoma. Eur J Ophthalmol. 2017 Aug 30;27(5):596-600. doi: 10.5301/ejo.5000940. Epub 2017 Feb 8.
Koehler PJ. Use of corticosteroids in neuro-oncology. Anticancer Drugs. 1995 Feb;6(1):19-33. doi: 10.1097/00001813-199502000-00002.
Sturdza A, Millar BA, Bana N, Laperriere N, Pond G, Wong RK, Bezjak A. The use and toxicity of steroids in the management of patients with brain metastases. Support Care Cancer. 2008 Sep;16(9):1041-8. doi: 10.1007/s00520-007-0395-8. Epub 2008 Feb 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019P000127
Identifier Type: -
Identifier Source: org_study_id