Rand Eye Institute, Deerfield Beach, Florida; Florida Atlantic University, Charles E. Schmidt School of Medicine, Boca Raton, Florida.
Sierra Eye Associates, Reno, Nevada; University of Nevada, Reno School of Medicine, Reno, Nevada.
Ophthalmol Retina. 2024 Nov;8(11):1052-1060. doi: 10.1016/j.oret.2024.04.023. Epub 2024 May 7.
To evaluate the impact of reduction in geographic atrophy (GA) lesion growth on visual acuity in the GATHER trials using categorical outcome measures.
Randomized, double-masked, sham-controlled phase 3 trials.
Aged ≥50 years with noncenter point-involving GA and best-corrected visual acuity (BCVA) of 25 to 80 ETDRS letters in the study eye.
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.
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.
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.
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.
使用分类结局衡量标准评估 GATHER 试验中减少地理萎缩（GA）病变进展对视力的影响。
随机、双盲、假对照的 3 期试验。
年龄≥50 岁，存在非中心累及点的 GA 且研究眼最佳矫正视力（BCVA）为 25 至 80 ETDRS 字母。
GATHER1 由两部分组成。在第 1 部分中，77 名患者按 1:1:1 的比例随机分配至阿柏西普 1mg、阿柏西普 2mg 和假治疗组。在第 2 部分中，209 名患者按 1:2:2 的比例随机分配至阿柏西普 2mg、阿柏西普 4mg 和假治疗组。在 GATHER2 中，患者按 1:1 的比例随机分配至阿柏西普 2mg（n=225）和假治疗组（n=223）。报告了汇总的阿柏西普 2mg 和假治疗组 12 个月数据的事后分析。
从基线到 12 个月时研究眼经历≥10、≥15 或≥20 个 BCVA ETDRS 字母损失的比例；从基线开始在 12 个月内至少连续 2 次就诊时发生持续视力损失≥10、≥15 或≥20 BCVA 字母的时间事件分析；在基线时符合驾驶条件的患者中，研究眼在 12 个月时视力损失降至低于驾驶合格阈值以下的比例。
与假治疗组（分别为 14.1%、7.6%和 4.5%）相比，阿柏西普 2mg 治疗组研究眼在 12 个月时经历≥10、≥15 或≥20 个 BCVA 字母损失的比例较低（分别为 11.6%、4.0%和 1.6%）。通过 12 个月，阿柏西普 2mg 治疗组发生持续损失≥15 BCVA ETDRS 字母的风险降低（3.4%对 7.8%）。与假治疗组相比，12 个月时，接受阿柏西普 2mg 治疗的研究眼达到驾驶不合格阈值的比例较低。
与假治疗相比，阿柏西普 2mg 治疗在 12 个月时延迟了进展为持续视力丧失（即≥10、≥15 和≥20 BCVA 字母损失或视力损失至低于驾驶合格阈值以下）的风险。
本文末尾的脚注和披露中可能存在专有或商业披露。
