Department of Ophthalmology, Weill Cornell Medical College, New York, New York.
Global Health Economics and Outcomes Research, Allergan plc, Irvine, California.
Ophthalmology. 2020 Sep;127(9):1179-1188. doi: 10.1016/j.ophtha.2020.02.027. Epub 2020 Feb 28.
To assess anti-vascular endothelial growth factor (VEGF) management patterns and anatomic and visual acuity (VA) outcomes among patients with neovascular age-related macular degeneration (nAMD) in United States clinical practice.
Retrospective observational cohort study.
Patients (N = 30 106) initiating intravitreal anti-VEGF treatment for nAMD between October 2009 and November 2016.
Analysis of longitudinal electronic health records from USRetina.
Number of intravitreal injections, OCT examinations, and fluorescein angiography (FA) examinations per study eye during the first 12 months; corrected VA and central retinal thickness (CRT) at 12 months; and number of ophthalmologist visits, stratified by index anti-VEGF agent.
Over the first 12 months, patients made a mean of 8.1 (range, 1-39) ophthalmologist visits, received a mean of 6.0 (range, 1-27) anti-VEGF injections, and underwent 7.2 OCT and 5.3 FA examinations per study eye. For eyes with paired baseline and 12-month readings, mean CRT declined from 320 to 271 μm (mean change, -48 μm), and mean VA increased from 60.3 to 61.0 approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letters (mean change, +0.6 letters). Twelve months after initiating index treatment with bevacizumab, ranibizumab, and aflibercept, 19.3%, 15.8%, and 15.5% of eyes, respectively, showed greater than 10-letter gain, whereas 13.2%, 14.7%, and 14.4% of eyes, respectively, showed greater than 10-letter loss. Mean change from baseline VA at 12 months increased linearly with cumulative anti-VEGF injection count: +1.79 versus -0.95 approximate ETDRS letters for eyes receiving 7 or more injections versus fewer than 7 injections. Similarly, the magnitude of the reduction from baseline CRT at 12 months tended to increase linearly with increasing number of anti-VEGF injections. Multivariate linear regression analysis, adjusted for covariates, indicated a significant association between cumulative number of anti-VEGF injections and change from baseline in VA at 12 months, with each unit increase producing an estimated gain of 0.37 approximate ETDRS letters.
This analysis of combined morphologic and functional outcomes of anti-VEGF therapy, the largest conducted to date in nAMD, identified relatively low anti-VEGF injection frequencies, coupled with moderate anatomic and limited VA improvements, in United States clinical practice.
评估美国临床实践中接受抗血管内皮生长因子（VEGF）治疗的新生血管性年龄相关性黄斑变性（nAMD）患者的抗 VEGF 管理模式以及解剖和视力（VA）结局。
回顾性观察性队列研究。
2009 年 10 月至 2016 年 11 月期间开始接受抗 VEGF 治疗的 nAMD 患者（N = 30106）。
分析来自美国视网膜的数据纵向电子健康记录。
在第 1 个月内每只研究眼的玻璃体腔内注射次数、OCT 检查和荧光素血管造影（FA）检查；第 12 个月时的矫正 VA 和中央视网膜厚度（CRT）；以及按索引抗 VEGF 药物分层的眼科就诊次数。
在最初的 12 个月内，患者平均进行了 8.1 次（范围为 1-39 次）眼科就诊，接受了 6.0 次（范围为 1-27 次）抗 VEGF 注射，并对每只研究眼进行了 7.2 次 OCT 和 5.3 次 FA 检查。对于基线和第 12 个月有配对读数的眼睛，CRT 均值从 320μm 下降到 271μm（平均变化-48μm），VA 均值从 60.3 提高到 61.0 个早期治疗糖尿病视网膜病变研究（ETDRS）字母（平均变化+0.6 个字母）。在接受贝伐单抗、雷珠单抗和阿柏西普治疗的索引治疗后 12 个月，分别有 19.3%、15.8%和 15.5%的眼睛 VA 增加超过 10 个字母，而分别有 13.2%、14.7%和 14.4%的眼睛 VA 下降超过 10 个字母。第 12 个月时 VA 从基线的平均变化与累积抗 VEGF 注射次数呈线性增加：接受 7 次或更多注射的眼睛为+1.79 个 ETDRS 字母，而接受少于 7 次注射的眼睛为-0.95 个 ETDRS 字母。同样，第 12 个月时 CRT 从基线的下降幅度也趋于随抗 VEGF 注射次数的增加而线性增加。经协变量调整的多变量线性回归分析表明，累积抗 VEGF 注射次数与第 12 个月时 VA 从基线的变化之间存在显著关联，每次增加一个单位估计可增加 0.37 个 ETDRS 字母。
对 nAMD 迄今为止最大规模的抗 VEGF 治疗形态和功能结局的分析显示，美国临床实践中抗 VEGF 注射频率相对较低，同时伴有中度的解剖学改善和有限的 VA 改善。
