Ciulla Thomas A, Huang Forbes, Westby Keith, Williams David F, Zaveri Sandi, Patel Samir C
Ophthotech Corporation, New York, New York.
Ophthotech Corporation, New York, New York.
Ophthalmol Retina. 2018 Jul;2(7):645-653. doi: 10.1016/j.oret.2018.01.006. Epub 2018 Mar 1.
Real-world visual outcomes of anti-vascular endothelial growth factor (anti-VEGF) therapy for neovascular age-related macular degeneration (nAMD) have been reported in cohorts outside of the United States. This study sought to assess the relationship between presenting visual acuity (VA) and visual outcomes, as well as the potential impact of loss to follow-up, in real-world anti-VEGF-treated nAMD patients from the United States.
Retrospective study of aggregated, longitudinal electronic medical records obtained from a geographically diverse sample of US retina specialists and included in the Vestrum Health Retina Database.
Inclusion criteria were a diagnosis of nAMD, no previous treatment, and ≥3 monthly anti-VEGF injections in the first 4 months from diagnosis in patients diagnosed between January 2011 and July 2013.
To model loss to follow-up, mutually exclusive cohorts of nAMD patients with loss to follow-up after specific time points of 6 and 12 months (i.e., no follow-up beyond) were compared with a separate cohort of patients who completed 24 months of follow-up ending prior to July 2015 (n = 2213).
VA outcomes were assessed on each cohort as a whole, with additional stratification by baseline VA.
The 6-, 12-, and 24-month cohorts received means of 5.4, 7.3, and 12.1 injections and showed no change, no change, and a mean change of +3.1 letters from baseline (95% confidence interval 1.8-4.4 letters, P < 0.01), respectively. When stratified by baseline VA, nearly all groups lose VA at their respective follow-up periods, except for those with baseline VA of 20/200 or worse.
Real-world nAMD patients in the United States receive fewer anti-VEGF injections and experience worse visual outcomes compared with patients in randomized clinical trials, consistent with non-US studies. Patients with better VA at presentation tend to be particularly vulnerable to vision loss. Compared with other patients, those ultimately lost to follow-up have worse visual outcomes at, or prior to, their final visit, suggesting that loss to follow-up may lead to overestimation of visual outcomes in clinical studies of nAMD.
在美国以外的队列研究中已报道了抗血管内皮生长因子（anti-VEGF）疗法治疗新生血管性年龄相关性黄斑变性（nAMD）的真实世界视觉效果。本研究旨在评估美国接受抗VEGF治疗的nAMD患者初始视力（VA）与视觉效果之间的关系，以及失访的潜在影响。
对从美国各地视网膜专家收集的汇总纵向电子病历进行回顾性研究，并纳入Vestrum Health视网膜数据库。
纳入标准为nAMD诊断、既往未接受治疗，以及在2011年1月至2013年7月诊断的患者中，诊断后前4个月内每月至少接受3次抗VEGF注射。
为模拟失访情况，将在6个月和12个月特定时间点后失访的nAMD患者相互排斥队列（即无后续随访）与在2015年7月之前完成24个月随访的另一队列患者（n = 2213）进行比较。
对每个队列整体评估VA结果，并按基线VA进行额外分层。
6个月、12个月和24个月队列分别接受了平均5.4次、7.3次和12.1次注射，与基线相比分别无变化、无变化以及平均变化+3.1字母（95%置信区间1.8 - 4.4字母，P < 0.01）。按基线VA分层时，除基线VA为20/200或更差的患者外，几乎所有组在各自随访期内视力均下降。
与随机临床试验中的患者相比，美国真实世界的nAMD患者接受的抗VEGF注射较少，视觉效果较差，这与美国以外的研究一致。初始视力较好的患者往往特别容易出现视力丧失。与其他患者相比，最终失访的患者在最后一次就诊时或之前的视觉效果更差，这表明失访可能导致nAMD临床研究中视觉效果的高估。
