Longitudinal Investigation of Dark Adaptation in Participants with AMD

年龄相关性黄斑变性（AMD）是一种迟发性进行性神经退行性疾病，影响全球2500万至3000万人。通过检眼镜和眼底摄影进行视力筛查和临床表征是识别和监测AMD的传统方法。虽然它们对表征疾病状态至关重要，但这些临床评估缺乏监测与疾病进展相关的功能性视力损害的其他方面的敏感性，例如黑暗适应；此外，直到AMD晚期，视力受到的影响最小。因此，有必要进行功能评估，以有效地识别和监测疾病进展的早期迹象，然后出现严重的视力丧失。这将是研究萎缩性AMD患者新疗法的潜在临床试验终点。本研究的目的是确定一种新的暗适应方案是否可以用作识别和监测AMD进展的功能结果测量。所有入选的参与者将接受相同的评估时间表，但他们将根据研究开始时的疾病严重程度分为四类（0-3组）。这项比较将研究AdaptRx暗适应方案在5年时间框架内检测不同疾病严重程度参与者的疾病进展（作为增加的棒细胞损伤的功能）的敏感性和可靠性。我们最近分析了4年的数据，并开始分析5年的结果。

Age-related macular degeneration (AMD) is a progressive neurodegenerative disease of late-onset that affects 25-30 million people worldwide. Vision screening and clinical characterization by ophthalmoscopic examination and fundus photography are the traditional measures used to identify and monitor AMD. While they are critical to characterizing disease status, these clinical assessments lack the sensitivity to monitor other aspects of functional visual impairment associated with disease progression such as dark adaptation; moreover, vision is minimally affected until advanced AMD. Consequently, there is a need for a functional assessment that effectively identifies and monitors early indications of disease progression prior to the onset of significant vision loss. This would be particularly useful as a potential clinical trial endpoint to investigate new therapeutics for patients with atrophic AMD. The objective of this study is to determine whether a new dark adaptation protocol can be used as a functional outcome measure to identify and monitor AMD progression. All enrolled participants will undergo the same assessment schedule, but they will be grouped into four categories (Groups 0-3) based on their disease severity at study entry. This comparison will investigate the sensitivity and reliability of the AdaptRx dark adaption protocol to detect disease progression (as a function of increased rod-cell impairment) over a 5-year time frame in participants with varying disease severity. We have recently analyzed 4 year data and moving to analyze 5 year results.