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Epimacular brachytherapy for previously treated neovascular age-related macular degeneration (MERLOT): 1 year safety and efficacy outcomes

Session Details

Session Title: AMD I

Session Date/Time: Thursday 17/09/2015 | 08:30-10:30

Paper Time: 10:22

Venue: Athena

First Author: : T.Jackson UNITED KINGDOM

Co Author(s): :    J. Neffendorf   R. Desai           

Abstract Details

PURPOSE:To assess the safety and efficacy of epimacular brachytherapy (EMB) adjunctive to anti-vascular endothelial growth factor therapy for patients with chronic, active, neovascular age-related macular degeneration (AMD), over 1 year

Setting:

24 United Kingdom sites

Methods:

A total of 363 adults with previously treated, active, neovascular AMD were enrolled into a randomized controlled trial. Participants were randomized 2:1 to 24 Gray EMB with monthly as needed (PRN) ranibizumab, or monthly PRN ranibizumab monotherapy. The co-primary outcome measures were the number of PRN ranibizumab injections, excluding any given at baseline for pre-existing disease activity, and the change in Early Treatment of Diabetic Retinopathy Study best corrected visual acuity (VA), both at 12 months. Secondary outcomes were the proportion of participants losing fewer than 15 letters, change in angiographic total lesion size, change in choroidal neovascularisation (CNV) size, and change in optical coherence tomography (OCT) foveal thickness. Angiograms and OCTs were graded by a central reading centre, to include detection of radiation-induced changes. Safety outcomes included adverse events (AEs) and serious AEs (SAEs)

Results:

At 12 months, the mean number of PRN ranibizumab injections was 4.8 in the EMB arm, and 4.1 in the ranibizumab arm (p = 0.068). The mean VA change was -4.8 letters in the EMB group and -0.9 letters in the ranibizumab monotherapy group (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 m in the EMB arm and by 15.7 m in the ranibizumab arm (P = 0.43). There was one case with a retinal vascular abnormality attributed to radiation in the EMB arm, but otherwise safety was acceptable

Conclusions:

These structural and functional efficacy results do not support the use of EMB as a second line treatment for chronic, active neovascular AMD. The safety results are acceptable at 12 months, but because radiation retinopathy can occur after one year, further follow-up is planned

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