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Lookup NU author(s): David Steel
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© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ. Background/aim: To assess the long-term safety and efficacy of epimacular brachytherapy (EMB) for chronic, active, neovascular age-related macular degeneration (nAMD). Methods: This pivotal, randomised, controlled surgical device trial recruited patients with chronic nAMD receiving intravitreal ranibizumab from 24 UK hospitals. Participants were randomised to either pars plana vitrectomy with 24 Gray EMB and pro re nata (PRN) ranibizumab (n=224) or PRN ranibizumab monotherapy (n=119). Although masking was not possible, masked clinicians assessed best-corrected visual acuity (BCVA) and imaging. After month 24, participants reverted to standard care, with either ranibizumab or aflibercept, returning for a month 36 study visit. Results: Of 363 participants, 309 (85.1%) completed month 36. The number of injections was 12.1±8.1 in the EMB group versus 11.4±6.1 in the ranibizumab group (difference 0.7, 95% CI of difference -0.9 to 2.3, p=0.41) between months 1 and 36, and 3.6±3.3 (n=200) versus 3.9±2.7 (n=102) (difference -0.3, 95% CI of difference -1.0 to 0.4, p=0.43) between months 25 and 36 (standard care). Over 36 months, BCVA change was -19.7±18.5 letters in the EMB group and -4.8±12.5 in the ranibizumab group (difference -14.9, 95% CI of difference -18.5 to -11.2, p<0.0001). The month 36 BCVA of 20 EMB-treated participants with microvascular abnormalities (MVAs) at month 24 was similar to EMB-treated participants without MVAs (-21.8 vs -19.4 letters, p=0.65). Conclusion: EMB does not reduce the number of anti-vascular endothelial growth factor (VEGF) injections, either within or outside of a trial setting, and is associated with worse BCVA than anti-VEGF monotherapy. Trial registration number: NCT01006538.
Author(s): Jackson TL, Soare C, Petrarca C, Simpson A, Neffendorf JE, Petrarca R, Muldrew KA, Peto T, Chakravarthy U, Membrey L, Haynes R, Costen M, Steel DHW, Desai R
Publication type: Article
Publication status: Published
Journal: British Journal of Ophthalmology
Year: 2023
Volume: 107
Issue: 7
Pages: 987-992
Print publication date: 01/07/2023
Online publication date: 25/02/2022
Acceptance date: 17/01/2022
ISSN (print): 0007-1161
ISSN (electronic): 1468-2079
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/bjophthalmol-2021-320620
DOI: 10.1136/bjophthalmol-2021-320620
PubMed id: 35217515
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