Vision Loss Reduction with Avacincaptad Pegol for Geographic Atrophy

IF 4.4 Q1 OPHTHALMOLOGY

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

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Abstract

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.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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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。

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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