Longitudinal Investigation of Dark Adaptation in Participants with AMD

AMD 参与者暗适应的纵向调查

• 批准号: 8556871
• 负责人: Catherine Cukras
• 金额: $ 13.64万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8556871
• 关键词: Affect; Age related macular degeneration; Blindness; Categories; Clinical; Clinical Trials; Clinical assessments; Dark Adaptation; Detection; Disease; Disease Progression; Elderly; Enrollment; Eye; Fundus photography; Impairment; Investigation; Measures; Mediating; Monitor; Neurodegenerative Disorders; Nonexudative age-related macular degeneration; Outcome Measure; Participant; Pathology; Patient Self-Report; Patients; Protocols documentation; Schedule; Severities; Severity of illness; Time; Vision; Vision Screening; Visual; Visual Acuity; Visual impairment; base; design; functional outcomes; novel; novel therapeutics; retinal rods

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.

老年性黄斑变性(AMD)是一种进行性神经退行性疾病，起病晚，影响全球2500万至3000万人。通过眼底检查和眼底照相进行视力筛查和临床表征是识别和监测AMD的传统手段。虽然它们对确定疾病状态至关重要，但这些临床评估缺乏监测与疾病进展相关的其他方面的功能性视觉损伤的敏感性，如暗适应；此外，在AMD晚期之前，视力受到的影响最小。因此，有必要进行功能评估，在严重视力丧失开始之前有效地识别和监测疾病进展的早期迹象。这对于研究萎缩性AMD患者的新治疗方法具有潜在的临床试验终点特别有用。这项研究的目的是确定一种新的暗适应方案是否可以作为一种功能性结果测量来识别和监测AMD进展。所有登记的参与者都将接受相同的评估计划，但他们将根据研究开始时的疾病严重程度被分成四个类别(0-3组)。这项比较将调查AdaptRx暗适应方案在不同疾病严重程度的参与者的5年时间框架内检测疾病进展(作为杆状细胞损伤增加的函数)的敏感性和可靠性。