印度使用布罗珠单抗治疗新生血管性年龄相关性黄斑变性（nAMD）的初步经验——多中心真实世界研究。
Initial experience with brolucizumab for neovascular age-related macular degeneration (nAMD) in India - Multicentric, real-world study.
作者信息
Singh Deependra Vikram, Agarwal Aniruddha, Goyal Anubhav, Shroff Daraius, Singh Jatinder, Kumar Pradeep, Reddy Raja Rami, Venkatesh Ramesh, Narnaware Shilpi, Joshi Shrinivas, Singh Deependra V, Narula Ritesh, Joshi Aishwarya, Agarwal Aniruddha, Goyal Anubhav, Gupta Charu, Shroff Daraius, Anantharaman Giridhar, Singh Jatinder, Kumar Pradeep, Bawankule Prashant, Reddy Raja Rami, Jain Rajiv, Venkatesh Ramesh, Tiwari Ruchir, Sugumar Shalini, Gupta Shashank Rai, Narnaware Shilpi, Joshi Shrinivas, Choudhary Somendra P
机构信息
Retina Department, Vitreo-retinal Services, Eye-Q Superspecialty Eye Hospitals Gurugram, Haryana, India.
Retina Department, The Eye Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates (UAE).
出版信息
Indian J Ophthalmol. 2024 Dec 1;72(12):1786-1794. doi: 10.4103/IJO.IJO_757_24. Epub 2024 Nov 29.
PURPOSE
To evaluate the anatomic and visual outcomes and safety profile of initial Indian eyes with neovascular age-related macular degeneration (nAMD) treated with intravitreal injection (IVI) of brolucizumab.
METHODS
This retrospective multicentric, real-world study enrolled consecutive eyes with nAMD that were treated with IVI brolucizumab after it was launched in India in October 2020. Data collected for each eye included best-corrected visual acuity (BCVA), central subfield thickness (CSFT), subretinal fluid (SRF), and intraretinal fluid (IRF) status at 6, 12, and 24 months follow-up. Also recorded were the lens status, treatment protocol, number of injections received before enrollment (in switch-over cases), total number of injections, and adverse effects noticed during the study period. Primary outcomes were change in BCVA, CSFT at follow-up visits, and incidence of intraocular inflammation (IOI). Secondary outcomes were profile of macular neovascularization, treatment protocols, mean number of injections, and maximum injection-free interval observed in eyes treated by pro-re-nata (PRN) protocol.
RESULTS
In total, 331 eyes received a mean of 3.55 ± 1.83 injections. Most frequent treatment protocol was PRN (53%). BCVA data was available for 100%, 96%, and 74% eyes at 6, 12, and 24 months follow-up. BCVA and CSFT improved significantly (P < 0.001) at all follow-ups. Two hundred and seventy-six (83.38%) out of 331 eyes received more than one injection; out of these, 241 (87.3%) eyes that were treated by PRN protocol could achieve mean "maximum injection-free interval" of 19.43 ± 8.82 weeks. IOI and retinal vasculitis were reported in 2.11% (7/331) and 0.60% (2/331) eyes, respectively. None of the eyes with IOI or vasculitis lost any vision at the final follow-up.
CONCLUSION
This study demonstrated favorable visual and anatomic outcomes and safety profile for eyes with nAMD treated by IVI brolucizumab. Mean maximum injection-free interval in eyes treated with PRN was 19 weeks.
目的
评估在印度初次接受玻璃体内注射布罗珠单抗治疗的新生血管性年龄相关性黄斑变性（nAMD）患者的眼部解剖结构、视力预后及安全性。
方法
这项回顾性多中心真实世界研究纳入了2020年10月布罗珠单抗在印度上市后连续接受玻璃体内注射布罗珠单抗治疗的nAMD患者。收集每只眼睛在随访6个月、12个月和24个月时的最佳矫正视力（BCVA）、中心子野厚度（CSFT）、视网膜下液（SRF）和视网膜内液（IRF）状态等数据。还记录了晶状体状态、治疗方案、入组前接受的注射次数（转用病例）、总注射次数以及研究期间观察到的不良反应。主要结局指标为随访时BCVA的变化、CSFT以及眼内炎症（IOI）的发生率。次要结局指标为黄斑新生血管形成情况、治疗方案、平均注射次数以及采用按需（PRN）方案治疗的眼睛观察到的最长无注射间隔时间。
结果
共有331只眼睛平均接受了3.55±1.83次注射。最常用的治疗方案是PRN（53%）。在随访6个月、12个月和24个月时，分别有100%、96%和74%的眼睛有BCVA数据。在所有随访中，BCVA和CSFT均有显著改善（P<0.001）。331只眼睛中有276只（83.38%）接受了不止一次注射；其中，采用PRN方案治疗的241只眼睛（87.3%）平均“最长无注射间隔时间”可达19.43±8.82周。分别有2.11%（7/331）和0.60%（2/331）的眼睛报告发生了IOI和视网膜血管炎。在最终随访时，发生IOI或血管炎的眼睛均未出现视力丧失。
结论
本研究表明，玻璃体内注射布罗珠单抗治疗nAMD患者的视力和解剖结构预后良好，安全性也较好。采用PRN方案治疗的眼睛平均最长无注射间隔时间为19周。
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