Jackson Timothy L, Soare Cristina, Petrarca Caroline, Simpson Andrew, Neffendorf James E, Petrarca Robert, Muldrew Katherine Alyson, Peto Tunde, Chakravarthy Usha, Membrey Luke, Haynes Richard, Costen Mark, Steel David H W, Desai Riti
Faculty of Life Sciences and Medicine, King's College London, London, UK
King's Ophthalmology Research Unit (KORU), King's College Hospital, London, UK.
Br J Ophthalmol. 2023 Jul;107(7):987-992. doi: 10.1136/bjophthalmol-2021-320620. Epub 2022 Feb 25.
BACKGROUND/AIM: To assess the long-term safety and efficacy of epimacular brachytherapy (EMB) for chronic, active, neovascular age-related macular degeneration (nAMD).
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 (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.
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, p0.41) 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, p0.0001). 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, p0.65).
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.
NCT01006538.
背景/目的：评估黄斑部近距离放射治疗（EMB）用于慢性、活动性、新生血管性年龄相关性黄斑变性（nAMD）的长期安全性和有效性。
这项关键的、随机、对照的手术器械试验招募了来自英国24家医院接受玻璃体内注射雷珠单抗治疗的慢性nAMD患者。参与者被随机分为接受24格雷EMB联合按需使用雷珠单抗的玻璃体切除术组（n = 224）或按需使用雷珠单抗单药治疗组（n = 119）。尽管无法进行设盲，但由设盲的临床医生评估最佳矫正视力（BCVA）和影像学检查结果。在第24个月后，参与者恢复接受标准治疗，使用雷珠单抗或阿柏西普，并返回进行第36个月的研究访视。
363名参与者中，309名（85.1%）完成了第36个月的随访。在第1至36个月期间，EMB组的注射次数为12.1±8.1次，而雷珠单抗组为11.4±6.1次（差值0.7，差值的95%置信区间为 -0.9至2.3，p = 0.41）；在第25至36个月（标准治疗阶段），注射次数分别为3.6± 3.3次（n = 200）和3.9±2.7次（n = 102）（差值 -0.3，差值的95%置信区间为 -1.0至0.4，p = 0.43）。在36个月期间，EMB组的BCVA变化为 -19.7±18.5个字母，雷珠单抗组为 -4.8±12.5个字母（差值 -14.9，差值的95%置信区间为 -18.5至 -11.2，p < 0.0001）。20名在第24个月有微血管异常（MVA）的接受EMB治疗的参与者在第36个月时的BCVA与没有MVA的接受EMB治疗的参与者相似（-21.8对 -19.4个字母，p = 0.65）。
在试验环境内或试验环境外，EMB均不能减少抗血管内皮生长因子（VEGF）的注射次数，并且与抗VEGF单药治疗相比，其BCVA更差。
NCT01006538。
