Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration (MERLOT): A Phase 3 Randomized Controlled Trial

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• 作者：Timothy L. Jackson ; PhD ; FRCOphth¹ ; ² ; ^{t.jackson1@nhs.net" class="auth_mail" title="E-mail the corresponding author} ; Riti Desai ; MPhil ; MSc² ; Andrew Simpson ; MBBS ; FRCOphth¹ ; ² ; James E. Neffendorf ; MA ; MBBS¹ ; ² ; Robert Petrarca ; MD (Res) ; FRCOphth¹ ; ² ; Kelly Smith ; MS³ ; Janet Wittes ; PhD³ ; Cornelius Lewis ; PhD¹ ; ⁴ ; Luke Membrey ; MD ; FRCOphth⁵ ; Richard Haynes ; MD ; FRCOphth⁶ ; Mark Costen ; FRCOphth⁷ ; David H.W. Steel ; FRCOphth⁸ ; Alyson Muldrew ; PhD⁹ ; Usha Chakravarthy ; PhD ; FRCOphth⁹ ; on behalf of the Macular Epiretinal Brachytherapy versus Ranibizumab (Lucentis) Only Treatment (MERLOT) Study Group^&lowast ;
• 关键词：AMD ; age-related macular degeneration ; BCVA ; best-corrected visual acuity ; CABERNET ; Choroidal Neovascularization Secondary to Age-Related Macular Degeneration Treated with Beta Radiation Epiretinal Therapy ; CNV ; choroidal neovascularization ; EMB ; epimacular brachytherapy ; ETDRS ; Early Treatment of Diabetic Retinopathy Study ; INTREPID ; IRay in Conjunction with Anti-VEGF Treatment for Patients with Wet AMD ; MERITAGE ; Macular Epiretinal Brachytherapy in Treated Age-Related Macular Degeneration ; ME
• 刊名：Ophthalmology
• 出版年：2016
• 出版时间：June 2016
• 年：2016
• 卷：123
• 期：6
• 页码：1287-1296
• 全文大小：891 K

文摘

To assess the safety and efficacy of epimacular brachytherapy (EMB) for patients with chronic, active, neovascular age-related macular degeneration (AMD).

Design

Phase 3 randomized controlled trial.

Participants

Patients (n = 363) with neovascular AMD already receiving intravitreal ranibizumab injections.

Intervention

Either 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 Measures

The 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.

Results

The 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.

Conclusions

These 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.