Department of Vitreo Retina and Uvea, Dr Shroff's Charity Eye Hospital, New Delhi, India.
Dr Muralidhar Eye Hospital, Bhubaneswar, Odisha, India.
Indian J Ophthalmol. 2024 Aug 1;72(8):1156-1161. doi: 10.4103/IJO.IJO_2973_23. Epub 2024 Jul 29.
Concerns about brolucizumab's (Pagenax®) association with intraocular inflammation (IOI) limit its use despite its cost-effectiveness and efficacy. This multicentric study analyzes IOI incidence across 21 tertiary eyecare centers in India since its introduction in October 2020.
To determine the real-world incidence rate of IOI in Indian patients secondary to intravitreal brolucizumab across 21 tertiary eye care centers in India.
Retrospective multicentric, survey-based study.
Data including number of patients treated, clinical indications, side effects encountered, and IOI case details was collected via Google Forms in 21 Indian tertiary eye care centers since October 2020. Mean, median, frequency, and standard deviation were calculated for statistical analysis.
All centers used pro re nata protocol for brolucizumab injections with a minimum injection interval of 8 weeks. The incidence of IOI was 0.79% (21 events out of 2655 eyes). Treatment indications included idiopathic polypoidal choroidal vasculopathy, neovascular age-related macular degeneration, diabetic macular edema, and off-label uses. IOI was experienced after the first injection (57%) in majority of cases with a median onset of 14 days (range: 1-65 days). IOI was mild in 28.5%, moderate in 33%, and severe in 38% of cases. Eighteen out of 21 IOI eyes recovered preinjection best corrected visual acuity or better.
Our study found a lower IOI incidence (0.79%) with brolucizumab (Pagenax) in Indian patients compared to previously reported literature. IOI events were mostly mild to moderate, and post-treatment, most patients improved or maintained BCVA. Larger prospective multicentric studies with PRN dosing protocol are needed to confirm these findings.
尽管抗 VEGF 药物 brolucizumab（Pagenax®）具有成本效益和疗效，但由于其与眼内炎症（IOI）相关的问题，限制了其使用。本多中心研究分析了 2020 年 10 月在印度推出以来，21 个三级眼科护理中心中接受玻璃体内 brolucizumab 治疗的患者的 IOI 发生率。
在印度的 21 个三级眼科护理中心中，确定玻璃体内 brolucizumab 治疗的印度患者的 IOI 真实世界发生率。
回顾性多中心、基于调查的研究。
自 2020 年 10 月以来，通过谷歌表格在印度的 21 个三级眼科护理中心收集了接受治疗的患者数量、临床适应证、不良反应以及 IOI 病例的详细信息。采用均数、中位数、频率和标准差进行统计分析。
所有中心均采用按需治疗方案（pro re nata protocol），brolucizumab 的最小注射间隔为 8 周。IOI 的发生率为 0.79%（2655 只眼中有 21 例）。治疗适应证包括特发性息肉样脉络膜血管病变、新生血管性年龄相关性黄斑变性、糖尿病性黄斑水肿和超适应证使用。多数患者（57%）在首次注射后出现 IOI，中位发病时间为 14 天（范围：1-65 天）。IOI 为轻度 28.5%、中度 33%、重度 38%。21 只 IOI 眼中有 18 只恢复了注射前的最佳矫正视力或更好。
与之前报道的文献相比，本研究发现印度患者使用 brolucizumab（Pagenax）的 IOI 发生率较低（0.79%）。IOI 事件多为轻度至中度，治疗后多数患者的 BCVA 改善或维持。需要更大规模的前瞻性多中心研究，采用 PRN 剂量方案，以证实这些发现。
