TY - JOUR
T1 - Epimacular brachytherapy for previously treated neovascular age-related macular degeneration
T2 - month 36 results of the MERLOT randomised controlled trial
AU - Jackson, Timothy L
AU - Soare, Cristina
AU - Petrarca, Caroline
AU - Simpson, Andrew
AU - Neffendorf, James E
AU - Petrarca, Robert
AU - Muldrew, Katherine Alyson
AU - Peto, Tunde
AU - Chakravarthy, Usha
AU - Membrey, Luke
AU - Haynes, Richard
AU - Costen, Mark
AU - Steel, David H W
AU - Desai, Riti
N1 - Funding Information:
TLJ received conference support and his employer received unrestricted research grant support from NeoVista. NeoVista had no role in data collection, analysis, or in the preparation or review of this manuscript. TLJ’s employer received free use of equipment from Oraya for an investigator-initiated trial of SRT, and his employer received research funding from Novartis for an unrelated project. His employer receives site payments for participants enrolled in various commercial clinical trials of AMD.
Funding Information:
Funded by an unrestricted research grant from NeoVista and supported by the National Institute of Health Research Comprehensive Clinical Research Network.
Publisher Copyright:
© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/2/25
Y1 - 2022/2/25
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85142395060&partnerID=8YFLogxK
U2 - 10.1136/bjophthalmol-2021-320620
DO - 10.1136/bjophthalmol-2021-320620
M3 - Article
C2 - 35217515
SN - 0007-1161
JO - The British journal of ophthalmology
JF - The British journal of ophthalmology
M1 - 320620
ER -