TREATMENT OF CHOROIDAL MELANOMA-ASSOCIATED EXUDATIVE RETINAL DETACHMENTS WITH A DEXAMETHASONE INTRAVITREAL IMPLANT BEFORE PROTON BEAM RADIATION

Vollständiger Abstract

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Purpose: To evaluate the safety and potential efficacy of a dexamethasone implant (Ozurdex) administered before proton radiation in patients with tumor-associated exudative retinal detachments. Methods: This was an investigator-initiated pilot study. Patients diagnosed with choroidal melanomas ≤10 mm thick, detachments spanning >2 clock hours, and visual acuity of 20/100 or better were randomized 1:1 to receive the dexamethasone implant or no treatment before proton radiation. Patients, masked to treatment completed during tumor localization surgery, were evaluated at 6, 14, 28, and 54 weeks after surgery. Efficacy end points included retinal detachment resolution, visual acuity preservation, and incidence of neovascular complications. Adverse events associated with the implant were monitored to ensure safety. Results: Baseline characteristics were similar between the dexamethasone (n = 5) and no treatment (n = 5) groups; median retinal detachment size was 4 clock hours at presentation in both groups. Four patients (80%) in each group had baseline visual acuity of 20/40 or better. At 12 months, the proportion of patients with resolution of retinal detachment was 40% in the dexamethasone group and 80% in the no treatment group; 60% in the dexamethasone group and 20% in the untreated group had visual acuity of 20/200 or worse. Known adverse effects of dexamethasone, cataract progression and elevated intraocular pressure, occurred in two patients and one patient, respectively, who received dexamethasone. Conclusion: Improved clinical outcomes were not observed in patients receiving the dexamethasone implant before proton radiation. No new safety concerns were identified with the use of dexamethasone in this cohort.