Supplementary Material for: Impact of Intravitreal Ranibizumab Therapy on Vision Outcomes in Diabetic Macular Edema Patients: A Meta-Analysis

Purpose: Evaluation of the impact of the injection frequency of ranibizumab on best-corrected visual acuity (BCVA) outcomes in patients with diabetic macular edema (DME). Methods: A meta-analysis of randomized controlled trials (RCTs) and real-world studies was performed to quantify the effect of ranibizumab treatment on BCVA and central foveal thickness (CFT) in DME as well as the relationship between the number of injections and the change in BCVA/CFT. Results: All combined sources (29 RCTs and 11 real-life studies) showed a significant increase in BCVA from baseline following anti-vascular endothelial growth factor (VEGF) treatment (8.2, 9.4, and 10.3 ETDRS letters gained after 12, 24, and 36 months of ranibizumab treatment, respectively). The largest changes in BCVA were observed in RCTs and the smallest in real-life studies at 12 months. A significant relationship was found between the number of injections and change in BCVA at 12 months. Conclusions: Inferior vision outcomes were observed in clinical practice compared with RCTs and might be partly attributable to administration of fewer anti-VEGF injections. Physicians should be aware that early and appropriate anti-VEGF treatment regimens are necessary to obtain the results reported in RCTs and help prevent irreversible vision loss in DME patients.

研究目的：评估雷珠单抗（ranibizumab）的注射频率对糖尿病黄斑水肿（Diabetic Macular Edema, DME）患者最佳矫正视力（Best-Corrected Visual Acuity, BCVA）预后的影响。
方法：本研究对随机对照试验（Randomized Controlled Trials, RCTs）与真实世界研究（real-world studies）开展荟萃分析，以量化雷珠单抗治疗DME患者对BCVA及中心凹厚度（Central Foveal Thickness, CFT）的作用，同时探究注射次数与BCVA/CFT变化之间的关联。
结果：纳入的全部综合研究数据源（29项RCTs与11项真实世界研究（real-life studies））均显示，接受抗血管内皮生长因子（anti-vascular endothelial growth factor, VEGF）治疗后，患者BCVA较基线水平显著提升：雷珠单抗治疗12、24及36个月后，患者分别获得8.2、9.4及10.3个ETDRS字母评分。治疗12个月时，RCTs亚组的BCVA提升幅度最大，真实世界研究亚组则最小；同时发现注射次数与12个月时的BCVA变化存在显著相关性。
结论：临床实践中患者的视力预后劣于RCTs报道结果，该差异可能部分源于抗VEGF注射次数偏少。临床医师需意识到，早期且规范的抗VEGF治疗方案是获得RCTs报道疗效的必要条件，有助于预防DME患者出现不可逆的视力丧失。