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.

中文翻译：

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参与年龄相关脉络膜新生血管 (IVAN) 试验中 VEGF 抑制的患者在解除方案后的长期视觉结果。

目的

描述退出试验的参与者的视力结果、治疗和监测就诊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) 开始使用贝伐珠单抗或雷珠单抗进行治疗。

设计

试验退出后长达 7 年的多中心队列研究。

参加者

参加年龄相关脉络膜新生血管 (IVAN) 抑制 VEGF 试验的患者；排除来自 2 个地点以及在试验期间死亡或退出的参与者后，该随访队列中纳入了 537 名参与者。

方法

数据收集于 2016 年 5 月 26 日至 2017 年 8 月 24 日之间。从所有参与者的医疗记录中提取双眼的远距离视力 (DVA)（读字母）以及在所有常规护理就诊时对任意一只眼睛进行的 nAMD 治疗，直到数据收集点（研究眼睛监测的持续时间）。

主要观察指标

使用多变量线性随机效应模型估计在主动监测研究眼（研究眼监测）期间 DVA 的变化率。其他结果指标包括就诊和治疗频率以及抗血管内皮生长因子（VEGF）药物的转换。

结果

获得了 99% (532/537) 合格参与者的数据。IVAN 退出后研究眼部监测的中位持续时间为 3.3 年（四分位数间距 [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 个（95% 置信区间 [CI]，3.7–4.9）个字母。调整关键协变量后，注射速率不会影响 DVA 的变化率。IVAN退出后，174名参与者（32%）没有接受治疗；358 人中的 332 人 (93%) 首先接受雷珠单抗治疗，其中 78 人 (23%) 改用阿柏西普。在研究监测结束时更换或未更换的参与者的 DVA 相似。

结论

IVAN 研究结束大约 5 年后，随着此类试验的随访达到前所未有的完整性，研究眼睛的功能下降轨迹被证明比之前报告的不完整试验队列更大。抗 VEGF 注射率和治疗转换并不是决定视力结果的重要因素。