Vitreoretinal Services, Centre for Sight, Safdarjung Enclave, New Delhi, India.
Indian J Ophthalmol. 2021 Feb;69(2):347-351. doi: 10.4103/ijo.IJO_2516_20.
: The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular membrane (CNVM), and macular edema secondary to retinal vein occlusion (RVO).
: We conducted a single-center, retrospective study, including patients with DME, CNVM, and RVO, who had received treatment with Razumab® between October 2018 and September 2019. Primary outcome measures were the changes in corrected distance visual acuity (CDVA) and central foveal thickness (CFT) from baseline to 1 month and 3 months. Secondary outcome measures included intraocular pressure (IOP) at day 1, any signs of ocular inflammation or systemic adverse events during the follow-up.
: One hundred and fifty-three eyes of 141 patients were analyzed. The indications included DME in 70 (45.8%) eyes, CNVM in 70 (45.8%) eyes, and RVO in 13 (8.4%) eyes. Mean CDVA improved from baseline (0.62 ± 0.44) to month 1 (0.45 ± 0.42) and maintained till 3 months (0.42 ± 0.44; P < 0.001). Mean CFT showed significant reduction from baseline (405.68 ± 192.422 μm) to month 1 (286.08 ± 118.36 μm) and month 3 (271 ± 104.24 μm; P < 0.001). None of the eyes recorded IOP >20 mmHg on day 1. No evidence of ocular toxicity or systemic adverse event was noted.
: Razumab® showed a rapid improvement in CDVA and CFT in most of the eyes with efficacy observed as early as 1 month and maintained till 3 months. The biosimilar Ranibizumab can be a safe and effective low-cost drug for treating macular diseases.
本研究旨在评估 Razumab（由 Intas Pharmaceuticals Ltd. 生产的雷珠单抗生物类似药）治疗脉络膜视网膜血管疾病（如糖尿病性黄斑水肿 [DME]、脉络膜新生血管 [CNVM] 和视网膜静脉阻塞 [RVO] 引起的黄斑水肿）的疗效和安全性。
我们进行了一项单中心、回顾性研究，纳入了 2018 年 10 月至 2019 年 9 月期间接受 Razumab®治疗的 DME、CNVM 和 RVO 患者。主要结局指标为从基线到 1 个月和 3 个月时校正后的距离视力（CDVA）和中央黄斑厚度（CFT）的变化。次要结局指标包括第 1 天的眼压（IOP）以及随访期间是否有任何眼部炎症或全身不良事件的迹象。
共分析了 141 例患者的 153 只眼。适应证包括 70 只（45.8%）眼 DME、70 只（45.8%）眼 CNVM 和 13 只（8.4%）眼 RVO。CDVA 从基线（0.62 ± 0.44）提高到 1 个月（0.45 ± 0.42），并在 3 个月时保持（0.42 ± 0.44；P < 0.001）。CFT 从基线（405.68 ± 192.422 μm）显著降低到 1 个月（286.08 ± 118.36 μm）和 3 个月（271 ± 104.24 μm；P < 0.001）。第 1 天没有记录到任何眼压 >20 mmHg 的眼睛。未观察到眼部毒性或全身不良事件的证据。
Razumab®在大多数患者中表现出快速改善 CDVA 和 CFT，在 1 个月时即可观察到疗效，并持续至 3 个月。雷珠单抗生物类似药可以作为一种安全有效的低成本药物，用于治疗黄斑疾病。
