Sun Hong, Li Ling, Bu Fengjiao, Xin Xiu, Yan Jingchao, Huang Taomin
Department of Pharmacy, Eye & ENT Hospital, Fudan University, Shanghai, China.
Eye (Lond). 2024 Dec;38(18):3473-3480. doi: 10.1038/s41433-024-03327-3. Epub 2024 Sep 11.
To compare the 2-year efficacy and safety of various anti-vascular endothelial growth factor (VEGF) regimens for neovascular age-related macular degeneration (nAMD).
A comprehensive search was performed on multiple electronic databases up to April 2023 and updated in June 2024, to identify relevant randomized controlled trials (RCTs). Key outcomes included the proportion of patients achieving a vision gain of ≥15 letters and maintaining stable vision (loss of <15 letters) in best-corrected visual acuity (BCVA), changes in mean BCVA from baseline, serious ocular adverse events (SAEs), adverse events leading to treatment discontinuation and any cause of death at 2 years.
Nineteen trials with 12,654 patients and 25 treatment regimens were analyzed in the study. All anti-VEGF regimens showed superior efficacy compared to sham therapy. Specifically, faricimab 6 mg (4+up to Q16W) and ranibizumab 0.5 mg (2-week T&E) displayed top-level effect in vision gain. Bevacizumab 1.25 mg (2-week T&E) and aflibercept 2 mg (2-week T&E) demonstrated the most stable vision outcomes. Bevacizumab 1.25 mg (2-week T&E) and ranibizumab 0.5 mg (2-week T&E) exhibited the most pronounced mean BCVA improvement. Compared to sham therapy, the risk of SAEs was significantly higher for brolucizumab 6 mg (3 + Q12W/ Q8W) (RR = 6.04, 95% CI: 1.30-28.02) and PDS 100 mg/ml (Q24W) (RR = 10.95, 95% CI: 2.14-56.02), but not for other anti-VEGF regimens.
Ranibizumab 0.5 mg (2-week T&E) emerges as a potentially optimal regimen for nAMD over a 2-year period. Future studies need to consider the impact of baseline characteristics on treatment outcomes.
比较各种抗血管内皮生长因子(VEGF)方案治疗新生血管性年龄相关性黄斑变性(nAMD)的2年疗效和安全性。
截至2023年4月对多个电子数据库进行全面检索,并于2024年6月更新,以识别相关的随机对照试验(RCT)。主要结局包括最佳矫正视力(BCVA)提高≥15个字母且视力保持稳定(下降<15个字母)的患者比例、BCVA较基线的平均变化、严重眼部不良事件(SAE)、导致治疗中断的不良事件以及2年时的任何死亡原因。
本研究分析了19项试验中的12654例患者和25种治疗方案。与假治疗相比,所有抗VEGF方案均显示出更高的疗效。具体而言,6mg法西单抗(4 + 直至每16周一次)和0.5mg雷珠单抗(每2周按需给药)在视力提高方面显示出顶级效果。1.25mg贝伐单抗(每2周按需给药)和2mg阿柏西普(每2周按需给药)显示出最稳定的视力结果。1.25mg贝伐单抗(每2周按需给药)和0.5mg雷珠单抗(每2周按需给药)的BCVA平均改善最为显著。与假治疗相比,6mg布罗珠单抗(3 + 每12周一次/每8周一次)(RR = 6.04,95%CI:1.30 - 28.02)和100mg/ml PDS(每24周一次)(RR = 10.95,95%CI:2.14 - 56.02)的SAE风险显著更高,但其他抗VEGF方案则不然。
0.5mg雷珠单抗(每2周按需给药)在2年期间成为nAMD潜在的最佳治疗方案。未来的研究需要考虑基线特征对治疗结果的影响。