Purpose

To perform an optical coherence tomography (OCT)-based analysis of geographic atrophy (GA) progression in patients treated with pegcetacoplan.

Design

Post hoc analysis of a phase 2 multicenter, randomized, sham-controlled trial.

Methods

Manual annotation of retinal pigment epithelium (RPE), ellipsoid zone (EZ), and external limiting membrane (ELM) loss was performed on OCT volumes from baseline and month 12 from the phase 2 FILLY trial of intravitreal pegcetacoplan for the treatment of GA secondary to age-related macular degeneration.

Main Outcome Measures

Correlation of GA areas measured on fundus autofluorescence and OCT. Difference in square root transformed growth rates of RPE, EZ, and ELM loss between treatment groups (monthly injection [AM], injection every other month [AEOM], and sham [SM]).

Results

OCT volumes from 113 eyes of 113 patients (38 AM, 36 AEOM, and 39 SM) were included, resulting in 11 074 B-scans. The median growth of RPE loss was significantly slower in the AM group (0.158 [0.057-0.296]) than the SM group (0.255 [0.188-0.359], P = .014). Importantly, the growth of EZ loss was also significantly slower in the AM group (0.127 [0.041-0.247]) than the SM group (0.232 [0.130-0.349], P = .017). There was no significant difference in the growth of ELM loss between the treatment groups (P = .114).

Conclusions

OCT imaging provided consistent results for GA growth compared with fundus autofluorescence. In addition to slower RPE atrophy progression in patients treated with pegcetacoplan, a significant reduction in EZ impairment was also identified by OCT, suggesting the use of OCT as a potentially more sensitive monitoring tool in GA therapy.

中文翻译：

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眼底自发荧光与基于光学相干断层扫描的 Pegcetacoplan 地图样萎缩治疗反应评估的比较

目的

对接受 pegcetacoplan 治疗的患者的地理萎缩 (GA) 进展进行基于光学相干断层扫描 (OCT) 的分析。

设计

2 期多中心、随机、假对照试验的事后分析。

方法

视网膜色素上皮 (RPE)、椭圆体区 (EZ) 和外界膜 (ELM) 损失的手动注释是在玻璃体内 pegcetacoplan 用于治疗继发性 GA 的 GA 继发性 GA 的 2 期 FILLY 试验的 2 期 FILLY 试验的基线和第 12 个月的 OCT 体积上进行的。年龄相关性黄斑变性。

主要观察指标

眼底自发荧光和 OCT 测量的 GA 面积的相关性。治疗组（每月注射[AM]、每隔一个月注射[AEOM]和假手术[SM]）之间RPE、EZ和ELM损失的平方根转化生长率的差异。

结果

包括 113 名患者（38 名 AM、36 名 AEOM 和 39 名 SM）113 只眼睛的 OCT 体积，产生 11 074 次 B 扫描。AM 组 (0.158 [0.057-0.296]) 的 RPE 损失中位数增长明显慢于 SM 组 (0.255 [0.188-0.359]，P  = 0.014)。重要的是，AM 组 (0.127 [0.041-0.247]) 的 EZ 损失增长也明显慢于 SM 组 (0.232 [0.130-0.349]，P  = 0.017)。治疗组之间 ELM 损失的增长没有显着差异 ( P  = .114)。

结论

与眼底自发荧光相比，OCT 成像为 GA 生长提供了一致的结果。接受 pegcetacoplan 治疗的患者除了减缓 RPE 萎缩进展外，OCT 还发现 EZ 损伤显着减少，这表明 OCT 可以作为 GA 治疗中更敏感的监测工具。