Purpose

The purpose of this study is to compare real-world visual acuity (VA) in patients with neovascular age-related macular degeneration (nAMD) treated with a single anti–vascular endothelial growth factor (VEGF) drug monotherapy for 1 year from the American Academy of Ophthalmology (AAO) Intelligent Research in Sight (IRIS) Registry.

Design

Retrospective, nonrandomized, comparative study.

Participants

IRIS Registry patients with nAMD who received bevacizumab, ranibizumab, or aflibercept only for 1 year between 2013–2016.

Methods

Participants were divided into 3 groups based on monotherapy type. Multivariate analysis of covariance models (ANCOVA) was constructed in a stepwise fashion.

Main Outcome Measures

The logarithm of the minimum angle of resolution (logMAR) VA at 1 year and mean change in logMAR VA between baseline and 1 year were compared between drug types.

Results

Of 13 859 patients, 6723 received bevacizumab, 2749 received ranibizumab, and 4387 received aflibercept only for 1 year. A total of 84 828 injections were performed. The mean number of injections (standard deviation) at 1 year was higher in the ranibizumab (6.4 [±2.4]) and aflibercept groups (6.2 [±2.4]) compared to bevacizumab group (5.9 [±2.4]; P < 0.0001). In the age-adjusted model, both ranibizumab and aflibercept achieved better logMAR VA at 1 year compared with bevacizumab (0.50 [±0.49], 0.49 [±0.44], 0.55 [±0.57]; P < 0.0001). However, this difference was not significant after multivariate adjustment (age, baseline VA, diabetes, posterior vitreous detachment, number of injections, race, insurance). There was no statistical difference in the age-adjusted or multivariate-adjusted mean logMAR VA change (standard deviation) at 1 year among treatment groups (−0.048 [0.44] bevacizumab, −0.053 [0.46] ranibizumab, −0.040 [0.39] aflibercept; P = 0.46). A higher percentage of patients achieved a ≥3-line VA improvement at 1 year in the bevacizumab group (22.7%) compared with ranibizumab (20.1%; P = 0.0093) and aflibercept (17.8%; P < 0.0001). However, after multivariate adjustment, aflibercept exhibited a greater log odds of a ≥3-line VA loss compared with bevacizumab only (1.25 log odds ratio; P < 0.0016).

Conclusions

This study suggests that all 3 drugs improve VA similarly over 1 year of monotherapy.

中文翻译：

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在IRIS注册中心中，使用单一抗VEGF药物类型治疗1年的年龄相关性黄斑变性患者的真实世界视野

目的

这项研究的目的是比较从美国科学院接受单一抗血管内皮生长因子（VEGF）药物单一疗法治疗的新生血管性年龄相关性黄斑变性（nAMD）患者1年的真实视力（VA）眼科（AAO）视觉智能研究（IRIS）注册中心。

设计

回顾性，非随机性，比较研究。

参加者

在2013年至2016年之间，仅接受1年贝伐单抗，兰尼单抗或aflibercept的IRIS登记处nAMD患者。

方法

根据单药治疗类型将参与者分为3组。以逐步方式构建了协方差模型（ANCOVA）的多元分析。

主要观察指标

比较了不同类型药物在1年时的最小分辨角（logMAR）VA的对数和基线与1年之间logMAR VA的平均变化。

结果

在13859名患者中，仅1年的患者中有6723名接受了贝伐单抗治疗，2749名接受了兰尼单抗治疗，4387名接受了aflibercept治疗。总共进行了84 828次注射。与贝伐单抗组（5.9 [±2.4]；P < 0.0001）相比，兰尼单抗（6.4 [±2.4]）和阿柏西普组（6.2 [±2.4]）在1年时的平均注射次数（标准差）更高。在年龄校正模型中，兰尼单抗和阿柏西普在1年时均比贝伐单抗获得更好的logMAR VA（0.50 [±0.49]，0.49 [±0.44]，0.55 [±0.57]；P < 0.0001）。但是，在进行多变量调整（年龄，基线VA，糖尿病，玻璃体后脱离，注射次数，种族，保险）后，这种差异并不显着。治疗组之间在1年时经年龄或多元调整后的平均logMAR VA变化（标准差）无统计学差异（-0.048 [0.44]贝伐单抗，-0.053 [0.46]雷尼单抗，-0.040 [0.39]阿柏西普；P = 0.46）。与兰尼单抗（20.1％; P = 0.0093）和aflibercept（17.8％; P <0.0001）。但是，经过多变量调整后，与仅贝伐单抗相比，阿柏西普表现出≥3线VA损失的对数优势（1.25对数优势比；P < 0.0016）。

结论

这项研究表明，所有3种药物在单一疗法治疗1年后都能类似地改善VA。