Long-term Visual Outcomes after Release from Protocol in Patients who Participated in the Inhibition of VEGF in Age-related Choroidal Neovascularisation (IVAN) Trial
Long-term Visual Outcomes after Release from Protocol in Patients who Participated in the Inhibition of VEGF in Age-related Choroidal Neovascularisation (IVAN) Trial
复制标题
DOI：
10.1016/j.ophtha.2020.03.020
复制
发表时间：
2020-09-01
期刊：
影响因子：
13.7
通讯作者：
Chakravarthy, Usha
中科院分区：
文献类型：
--
作者：
Evans, Rebecca N.;Reeves, Barnaby C.;Chakravarthy, Usha
目的：描述退出试验的参与者的视力结果、治疗和监测访视的频率以及常规护理中使用的抗血管内皮生长因子药物，在该试验中，新生血管性年龄相关性黄斑变性（nAMD）的治疗开始于贝伐单抗或雷珠单抗。设计：多中心队列研究，试验退出后长达7年。参加了血管内皮生长因子抑制相关脉络膜新生血管形成（IVAN）试验的患者;在排除了2个研究中心的参与者以及在试验期间死亡或退出的参与者后，537例患者被纳入该随访队列。数据收集时间为2016年5月26日至2017年8月24日。从所有参与者的医疗记录中提取双眼的远视力（DVA）（读字母）和在所有常规护理访视时给予任一只眼睛的nAMD治疗，直到数据收集点（研究眼睛监测的持续时间）。主要结果测量：在研究眼睛的主动监测（研究眼睛监测）期间DVA的变化率，使用多变量线性随机效应模型估计。其他结果的措施是访问和治疗频率和开关在抗血管内皮生长因子（VEGF）drug.Results：数据获得了99%（532/537）的合格参与者。IVAN退出后研究眼监测的中位持续时间为3.3年（四分位距[IQR]，1.3 - 4.7），中位DVA为58.0个字母（IQR，34.0 - 73.0）。研究眼DVA每年恶化4.3（95%置信区间[CI]，3.7 - 4.9）个字母。在调整关键协变量后，注射速率不影响DVA的变化率。IVAN退出后，174名参与者（32%）未接受治疗; 358名参与者中有332名（93%）首先接受了雷珠单抗治疗，其中78名（23%）转为阿柏西普治疗。DVA是相似的参与者之间切换或不切换在研究monitoring.Conclusions结束后，IVAN研究完成，前所未有的完整性，这样的试验后续，轨迹的功能下降的研究眼睛被证明是大于以前报告的不完整的试验队列。抗VEGF注射率和治疗转换不是决定视力结果的重要因素。(C)2020年，美国眼科学会。
Purpose: To describe visual outcomes, frequency of treatment and monitoring visits, and anti-vascular endothelial growth factor drugs used in usual care in participants who exited a trial in which treatment for neovascular age-related macular degeneration (nAMD) was initiated with bevacizumab or ranibizumab.Design: Multicenter cohort study up to 7 years after trial exit.Participants: Patients enrolled in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial; after excluding participants from 2 sites and who died or withdrew during the trial, 537 were included in this follow-up cohort.Methods: Data were collected between May 26, 2016, and August 24, 2017. Distance visual acuity (DVA) (letters read) in both eyes and treatments for nAMD administered to either eye at all usual care visits were extracted from medical records of all participants until the point of data collection (duration of study eye monitoring).Main Outcome Measures: Rate of change of DVA during active surveillance of the study eye (study eye monitoring), estimated using a multivariable linear random effects model. Other outcome measures were visit and treatment frequency and switches in anti-vascular endothelial growth factor (VEGF) drug.Results: Data were obtained for 99% (532/537) of eligible participants. The median duration of study eye monitoring after IVAN exit was 3.3 years (interquartile range [IQR], 1.3-4.7), and median DVA was 58.0 letters (IQR, 34.0-73.0). Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year. Injection rate did not influence the rate of change in DVA after adjusting for key covariates. After IVAN exit, 174 participants (32%) received no treatment; 332 of 358 (93%) were treated first with ranibizumab, 78 (23%) of whom switched to aflibercept. The DVA was similar among participants who switched or did not switch at the end of study monitoring.Conclusions: Approximately 5 years after the IVAN study finished, with unprecedented completeness of follow-up for such a trial, the trajectory of functional decline in the study eye was shown to be greater than that previously reported for incomplete trial cohorts. Anti-VEGF injection rates and treatment switches were not important factors in determining visual acuity outcomes. (C) 2020 by the American Academy of Ophthalmology.