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比较基于眼底自发荧光和光相干断层扫描的培格司亭治疗地图状萎缩的疗效评估。

Comparison of Fundus Autofluorescence Versus Optical Coherence Tomography-based Evaluation of the Therapeutic Response to Pegcetacoplan in Geographic Atrophy.

机构信息

From the OPTIMA-Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.

From the OPTIMA-Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.

出版信息

Am J Ophthalmol. 2022 Dec;244:175-182. doi: 10.1016/j.ajo.2022.06.023. Epub 2022 Jul 16.

Abstract

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.

摘要

目的

对接受培塞利珠单抗治疗的患者中地图样萎缩(GA)进展进行基于光相干断层扫描(OCT)的分析。

设计

一项 2 期多中心、随机、假对照试验的事后分析。

方法

对 2 期 FILLY 试验中玻璃体内培塞利珠单抗治疗与年龄相关性黄斑变性相关的 GA 的 OCT 卷进行视网膜色素上皮(RPE)、椭圆体带(EZ)和外界膜(ELM)丧失的手动注释。

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 2 个月注射[AEOM]和假[SM])之间 RPE、EZ 和 ELM 丧失的平方根转化增长率差异。

结果

纳入了 113 名患者 113 只眼的 OCT 容积,共 11074 个 B 扫描。AM 组的 RPE 丧失中位增长率明显较慢(0.158 [0.057-0.296]),低于 SM 组(0.255 [0.188-0.359],P = 0.014)。重要的是,AM 组 EZ 丧失的增长率也明显较慢(0.127 [0.041-0.247]),低于 SM 组(0.232 [0.130-0.349],P = 0.017)。治疗组之间 ELM 丧失的增长率无显著差异(P = 0.114)。

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。除了接受培塞利珠单抗治疗的患者 RPE 萎缩进展较慢外,OCT 还发现 EZ 损伤明显减少,提示 OCT 可能成为 GA 治疗的一种更敏感的监测工具。

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