阿伐卡塔哌啶治疗地理萎缩可减少视力损失：GATHER1 和 GATHER2 试验的 12 个月事后分析。

IF 4.4 Q1 OPHTHALMOLOGY

Ophthalmology. Retina Pub Date : 2024-11-01 DOI:10.1016/j.oret.2024.04.023

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引用次数: 0

摘要

目的：在 GATHER 试验中，使用分类结果测量法评估减少地理萎缩（GA）病灶生长对视力的影响：随机、双掩蔽、假对照 3 期试验：年龄≥50岁，非中心点涉及GA，研究眼最佳矫正视力（BCVA）为25-80个早期治疗糖尿病视网膜病变研究（ETDRS）字母：GATHER1 包括两个部分。在第一部分中，77 名患者按 1:1:1 的比例随机分配到阿伐卡托匹考（ACP）1 毫克、ACP 2 毫克和假药中。在第 2 部分中，209 名患者以 1:2:2 的比例被随机分配到 ACP 2 毫克、ACP 4 毫克和假体中。在 GATHER2 中，患者按 1:1 随机分配到 ACP 2 毫克（225 人）和假体（223 人）。报告对ACP 2 mg和假药组12个月的数据进行了事后分析：从基线到第12个月，ETDRS字母损失≥10、≥15或≥20-BCVA的研究眼比例；在12个月内≥2次连续就诊时，视力从基线持续下降≥10、≥15或≥20-BCVA字母的时间到事件分析；在基线时符合驾驶条件的人中，第12个月时BCVA下降到低于驾驶资格阈值的研究眼比例：使用ACP 2 mg（分别为11.6%、4.0%和1.6%）与假性ACP 2 mg（分别为14.1%、7.6%和4.5%）相比，12个月内BCVA视力从基线下降≥10个字母、≥15个字母或≥20个字母的研究对象比例较低。使用 ACP 2 毫克（3.4%）与假眼药（7.8%）治疗 12 个月后，ETDRS 字数≥15-BCVA 持续损失的风险有所降低。接受ACP 2 mg治疗的眼球在12个月内达到无驾驶资格阈值的比例低于假性眼球：ACP 2 毫克与假视力表相比，在 12 个月内，ACP 2 毫克治疗可延缓视力持续下降（即视力下降≥10 个、≥15 个和≥20 个 BCVA 字元，或 BCVA 下降到低于驾驶资格阈值的水平）的风险。

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Vision Loss Reduction with Avacincaptad Pegol for Geographic Atrophy

Purpose

To evaluate the impact of reduction in geographic atrophy (GA) lesion growth on visual acuity in the GATHER trials using categorical outcome measures.

Design

Randomized, double-masked, sham-controlled phase 3 trials.

Participants

Aged ≥50 years with noncenter point-involving GA and best-corrected visual acuity (BCVA) of 25 to 80 ETDRS letters in the study eye.

Methods

GATHER1 consisted of 2 parts. In part 1, 77 patients were randomized 1:1:1 to avacincaptad pegol (ACP) 1 mg, ACP 2 mg, and sham. In part 2, 209 patients were randomized 1:2:2 to ACP 2 mg, ACP 4 mg, and sham. In GATHER2, patients were randomized 1:1 to ACP 2 mg (n = 225) and sham (n = 223). A post hoc analysis of 12-month data for pooled ACP 2 mg and sham groups is reported.

Main Outcome Measures

Proportion of study eyes that experienced ≥10-, ≥15-, or ≥20-BCVA ETDRS letter loss from baseline to month 12; time-to-event analysis of persistent vision loss of ≥10, ≥15, or ≥20 BCVA letters from baseline at ≥2 consecutive visits over 12 months; proportion of study eyes with BCVA loss to a level below driving eligibility threshold at month 12 among those eligible to drive at baseline.

Results

Lower proportions of study eyes experienced ≥10-, ≥15-, or ≥20-BCVA letter loss from baseline over 12 months with ACP 2 mg (11.6%, 4.0%, and 1.6%, respectively) versus sham (14.1%, 7.6%, and 4.5%, respectively). There was a reduction in the risk of persistent loss of ≥15 BCVA ETDRS letters with ACP 2 mg (3.4%) versus sham (7.8%) through 12 months. A lower proportion of study eyes treated with ACP 2 mg reached the threshold for driving ineligibility versus sham by 12 months.

Conclusions

Treatment with ACP 2 mg delayed the risk of progression to persistent vision loss (i.e., ≥10-, ≥15-, and ≥20-BCVA letter loss or BCVA loss to a level below driving eligibility threshold) versus sham over 12 months.