Department of Ophthalmology, Centro Hospitalar Universitário de São João, Porto, Portugal,
Department of Surgery and Physiology, Faculty of Medicine, University of Porto, Porto, Portugal,
Ophthalmologica. 2020;243(4):243-254. doi: 10.1159/000505070. Epub 2019 Nov 28.
Evaluation of the impact of the injection frequency of ranibizumab on best-corrected visual acuity (BCVA) outcomes in patients with diabetic macular edema (DME).
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.
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.
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.
评估雷珠单抗注射频率对糖尿病黄斑水肿(DME)患者最佳矫正视力(BCVA)结局的影响。
对随机对照试验(RCT)和真实世界研究进行荟萃分析,以量化雷珠单抗治疗对 DME 患者的 BCVA 和中心凹视网膜厚度(CFT)的影响,以及注射次数与 BCVA/CFT 变化之间的关系。
所有联合来源(29 项 RCT 和 11 项真实世界研究)均显示,抗血管内皮生长因子(VEGF)治疗后 BCVA 从基线显著增加(分别在雷珠单抗治疗 12、24 和 36 个月后增加 8.2、9.4 和 10.3 ETDRS 字母)。在 12 个月时,RCT 中观察到的 BCVA 变化最大,而真实世界研究中观察到的 BCVA 变化最小。在 12 个月时,注射次数与 BCVA 变化之间存在显著关系。
与 RCT 相比,临床实践中观察到的视力结果较差,这可能部分归因于抗 VEGF 注射次数较少。医生应该意识到,早期和适当的抗 VEGF 治疗方案对于获得 RCT 报告的结果以及帮助预防 DME 患者视力不可逆转丧失是必要的。