To compare fundus autofluorescence (FAF) and spectral domain optical coherence tomography (OCT) measurements of geographic atrophy (GA) area and to analyze lesion area changes measured by spectral domain OCT in GATHER1. An assessment reliability analysis using prospective, randomized, double-masked phase 2/3 clinical trial data. GATHER1 examined the efficacy and safety of avacincaptad pegol (ACP) for GA treatment. A post hoc analysis was performed to identify correlations between FAF- and OCT-based measurements of GA. GA area was measured on blue-light FAF images using semiautomatic segmentation software with support from OCT and near-infrared imaging. Machine-learning enhanced, multilayer segmentation of OCT scans were reviewed by human readers, and segmentation errors were corrected as needed. GA area was defined as total RPE loss on cross-sectional B scans. Time points included Months 0, 6, 12, and 18. Additionally, OCT-based GA-area changes between ACP and sham were analyzed. There was a strong correlation (r = 0.93) between FAF and OCT GA area measurements that persisted through 18 months. Mean (SD) differences between OCT and FAF GA measurements were negligible: 0.11 mm (1.42) at Month 0, 0.03 mm (1.62) at Month 6, −0.17 mm (1.81) at Month 12, and −0.07 mm (1.78) at Month 18. OCT assessments of GA growth revealed a 30% and 27% reduction at Months 12 and 18, respectively, between ACP and sham, replicating FAF measurements from GATHER1. The strong correlation between blue FAF and OCT measurements of GA area supports OCT as a reliable method to measure GA lesion area in clinical trials.

中文翻译：

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干性年龄相关性黄斑变性中蓝色眼底自发荧光与地理萎缩的 SD-OCT 测量之间的相关性


比较地理萎缩 (GA) 区域的眼底自发荧光 (FAF) 和频域光学相干断层扫描 (OCT) 测量结果，并分析 GATHER1 中频域 OCT 测量的病变区域变化。使用前瞻性、随机、双盲 2/3 期临床试验数据进行评估可靠性分析。 GATHER1 检查了 avacincaptad pegol (ACP) 用于 GA 治疗的有效性和安全性。进行事后分析以确定基于 FAF 和 OCT 的 GA 测量之间的相关性。在 OCT 和近红外成像的支持下，使用半自动分割软件在蓝光 FAF 图像上测量 GA 面积。机器学习增强的 OCT 扫描多层分割由人类读者进行审查，并根据需要纠正分割错误。 GA 面积定义为横截面 B 扫描上的总 RPE 损失。时间点包括第 0、6、12 和 18 个月。此外，还分析了 ACP 和假手术之间基于 OCT 的 GA 面积变化。 FAF 和 OCT GA 面积测量之间存在很强的相关性 (r = 0.93)，这种相关性持续了 18 个月。 OCT 和 FAF GA 测量值之间的平均 (SD) 差异可以忽略不计：第 0 个月为 0.11 mm (1.42)，第 6 个月为 0.03 mm (1.62)，第 12 个月为 -0.17 mm (1.81)，第 12 个月为 -0.07 mm (1.78)。第 18 个月。对 GA 生长的 OCT 评估显示，在第 12 个月和第 18 个月，ACP 和假手术之间分别减少了 30% 和 27%，复制了 GATHER1 的 FAF 测量结果。蓝色 FAF 和 GA 区域的 OCT 测量之间的强相关性支持 OCT 作为临床试验中测量 GA 病变区域的可靠方法。