Purpose

To explore various methods for assessing the early response to vascular endothelial growth factor (VEGF) inhibitors for neovascular age-related macular degeneration and investigate their association with 3-year visual acuity (VA) outcomes.

Design

Database study, prospectively designed.

Participants

Treatment-naïve eyes in the Fight Retinal Blindness! registry that commenced anti-VEGF therapy between January 1, 2007, and March 1, 2014, that received 3 anti-VEGF injections within the first 3 months.

Methods

The early response was defined as occurring up until the fourth injection. Various early response metrics were explored: (1) achieving good VA (≥70 letters; Snellen equivalent, 20/40), (2) absolute change in VA from baseline, (3) time to first grading of the choroidal neovascular lesion as inactive, and (4) maximum rate of VA change between successive injections.

Main Outcome Measures

Proportion of eyes achieving ≥70 letters 3 years.

Results

This study included 2051 treatment-naïve eyes from 1828 patients. Achieving good vision at 3 years was associated significantly with (1) having good vision by the fourth injection (VA ≥70 vs. VA <70 letters: odds ratio [OR], 9.8; 95% confidence interval [CI], 6.5–14.7), (2) small (1–5 letters) or large (>5 letters) early VA gains (vs. early VA loss: OR, 1.8; 95% CI, 1.2–2.6; P = 0.002; and OR, 1.8; 95% CI, 1.3–2.5; P < 0.001), (3) fewer injections until first grading of lesion inactivity (≤3 vs. >3 injections: OR, 1.6; 95% CI, 1.2–2.1; P < 0.001), (4) gradual change (between –4 and 4 letters) or rapid gains (≥5 letters) between successive injections (vs. rapid loss: OR, 1.7; 95% CI, 1.1–2.6; P = 0.015; and OR, 1.6; 95% CI, 1.1–2.3; P = 0.018). Eyes that achieved small or large early gains had similar vision at 3 years (65.0 and 64.7 letters, respectively) and had better vision than eyes with early VA loss (57.2 letters).

Conclusions

Attainment of good vision by the fourth injection was associated strongly with 3-year visual outcomes, whereas other early response parameters showed a moderate association. The early response during the initial 3 monthly injections can be a useful guide for subsequent treatment decisions.

中文翻译：

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基于新生血管年龄相关性黄斑变性的初始治疗反应的长期视力结果预测

目的

探索各种方法来评估对新生血管性年龄相关性黄斑变性的血管内皮生长因子（VEGF）抑制剂的早期反应，并研究它们与3年视力（VA）结果的关联。

设计

数据库研究，经过前瞻性设计。

参加者

对抗视网膜失明的未经治疗的眼睛！在2007年1月1日至2014年3月1日期间开始抗VEGF治疗的注册中心，在前3个月内接受了3次抗VEGF注射。

方法

早期反应被定义为直到第四次注射为止。探索了各种早期反应指标：（1）达到良好的VA（≥70个字母； Snellen当量，20/40），（2）从基线开始的VA绝对变化，（3）脉络膜新生血管病变不活动时的第一次分级，以及（4）两次连续注射之间的最大VA变化率。

主要观察指标

3年内达到≥70个字母的眼睛比例。

结果

这项研究包括来自1828例患者的2051例未经治疗的眼睛。在3年时获得良好的视力与（1）第四次注射具有良好的视力显着相关（VA≥70vs. VA <70字母：优势比[OR]为9.8； 95％置信区间[CI]为6.5-14.7 ），（2）早期VA增加的小（1-5个字母）或大（> 5个字母）（相对于早期VA损失：OR，1.8； 95％CI，1.2-2.6；P  = 0.002； OR，1.8； 95％CI，1.3–2.5；P <0.001），（3）更少的注射，直到病变无活动性分级（≤3vs.> 3注射：OR，1.6； 95％CI，1.2–2.1；P <0.001）， （4）连续注射之间的逐渐变化（–4至4个字母之间）或快速增益（≥5个字母）（与快速丢失相比：OR为1.7； 95％CI为1.1-2.6；P  = 0.015； OR为1.6 ； 95％CI，1.1-2.3；P  = 0.018）。早期获得较小或较大收获的眼睛在3年时的视力相似（分别为65.0和64.7个字母），并且比早期VA丧失的眼睛（57.2个字母）具有更好的视力。

结论

第四次注射达到良好的视力与3年的视觉结果密切相关，而其他早期反应参数则显示出中等程度的关联。最初的三个月注射期间的早期反应可以为后续治疗决策提供有用的指导。