L V Prasad Eye Institute, Hyderabad Eye Research Foundation, Hyderabad, Telangana, India.
National Institute of Ophthalmology, Pune, Maharashtra, India.
BMC Ophthalmol. 2021 Jan 12;21(1):33. doi: 10.1186/s12886-020-01757-7.
Macular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision. Intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) are the standard of care in this disease, as shown in numerous randomized controlled trials. The purpose of this study was to study the efficacy and safety of ranibizumab, an anti-VEGF agent, in the real-world setting.
This was 48 weeks, open-label, prospective, multicentre, observational study. Patients diagnosed with ME secondary to RVO were treated with IVI of Ranibizumab 0.5 mg in real-world conditions. Efficacy was measured by improvement seen in best-corrected visual acuity (BCVA) in terms of Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores and change in central retinal thickness (CRT) measured by optical coherence tomography.
One hundred eyes of 100 patients (79 with branch retinal vein occlusion and 21 with central retinal vein occlusion) were recruited in the study. The mean (standard deviation, SD) BCVA was 52.8 (21.99) letters at baseline and 62.3 (24.40) letters at week 48. From baseline, there was a significant improvement in BCVA by 7.7 letters (p = 0.001) at 48 weeks. The mean (SD) of CRT was 479.9 (216.25) μm at baseline and it decreased significantly to 284.9 (171.35) μm at week 48 (p < 0.001). During the study period, the average number of intravitreal injections was 3.5 per patient. There was no report of endophthalmitis in any eye.
Ranibizumab is well tolerated and effective in treating macular edema secondary to RVO in real-world clinical settings. However, there is under-treatment compared to controlled clinical trials, and the gain in vision is sub-optimal with under-treatment.
Clinical Trials Registry - India: CTRI/2015/07/005985 .
视网膜静脉阻塞（RVO）引起的黄斑水肿是视力丧失的一个重要原因。玻璃体内注射抗血管内皮生长因子（VEGF）已成为治疗该疾病的标准方法，这在大量随机对照试验中得到了证实。本研究的目的是研究抗 VEGF 药物雷珠单抗在真实世界环境中的疗效和安全性。
这是一项为期 48 周的开放性、前瞻性、多中心、观察性研究。在真实世界条件下，将诊断为 RVO 继发 ME 的患者用雷珠单抗 0.5mg 行玻璃体内注射治疗。通过最佳矫正视力（BCVA）中 ETDRS 字母评分的改善和光学相干断层扫描（OCT）测量的中心视网膜厚度（CRT）的变化来评估疗效。
本研究共纳入 100 例患者（79 例为分支视网膜静脉阻塞，21 例为中央视网膜静脉阻塞）的 100 只眼。基线时的平均（标准差，SD）BCVA 为 52.8（21.99）个字母，48 周时为 62.3（24.40）个字母。与基线相比，48 周时 BCVA 显著提高了 7.7 个字母（p=0.001）。基线时 CRT 的平均值（SD）为 479.9（216.25）μm，在第 48 周时显著降低至 284.9（171.35）μm（p<0.001）。在研究期间，每位患者平均接受 3.5 次玻璃体内注射。没有任何一只眼报告眼内炎。
雷珠单抗在真实世界临床环境中治疗 RVO 引起的黄斑水肿是安全且有效的。然而，与对照临床试验相比，治疗不足，并且治疗不足导致视力改善不理想。
印度临床试验注册处：CTRI/2015/07/005985。
