Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration (MERLOT) A Phase 3 Randomized Controlled Trial Presented in part at: Retina Day, American Academy of Ophthalmology Annual Meeting, November 2015, Las Vegas, Nevada.

Abstract

PurposeTo assess the safety and efficacy of epimacular brachytherapy (EMB) for patients with chronic, active, neovascular age-related macular degeneration (AMD).DesignPhase 3 randomized controlled trial.ParticipantsPatients (n = 363) with neovascular AMD already receiving intravitreal ranibizumab injections.InterventionEither pars plana vitrectomy with 24-gray EMB and ongoing pro re nata (PRN) ranibizumab (n = 224) or ongoing PRN ranibizumab monotherapy (n = 119).Main Outcome MeasuresThe coprimary outcomes, at 12 months, were the number of PRN ranibizumab injections and Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (VA). Secondary outcomes included the proportion of participants losing fewer than 15 ETDRS letters, angiographic total lesion size, choroidal neovascularization (CNV) size, and optical coherence tomography (OCT) foveal thickness. A predefined subgroup analysis tested the influence of baseline ocular characteristics on the response to EMB.ResultsThe mean number of PRN ranibizumab injections was 4.8 in the EMB arm and 4.1 in the ranibizumab monotherapy arm (P = 0.068). The mean VA change was −4.8 letters in the EMB arm and −0.9 letters in the ranibizumab arm (95% confidence interval of difference between groups, −6.6 to −1.8 letters). The proportion of participants losing fewer than 15 letters was 84% in the EMB arm and 92% in the ranibizumab arm (P = 0.007). In the EMB arm, the mean total lesion size increased by 1.2 mm2 versus 0.4 mm2 in the ranibizumab arm (P = 0.27). The CNV size decreased by 0.5 mm2 in the EMB arm and by 1.3 mm2 in the ranibizumab arm (P = 0.27). The OCT foveal thickness decreased by 1.0 μm in the EMB arm and by 15.7 μm in the ranibizumab arm (P = 0.43). Most subgroups favored ranibizumab monotherapy, some significantly so. One participant showed retinal vascular abnormality attributed to radiation, but otherwise safety was acceptable.ConclusionsThese results do not support the use of EMB for chronic, active, neovascular AMD. Safety is acceptable out to 12 months, but radiation retinopathy can occur later, so further follow-up is planned