Longitudinal Investigation of Dark Adaptation in Participants with AMD

AMD 参与者暗适应的纵向调查

• 批准号: 10930519
• 负责人: Catherine Cukras
• 金额: $ 29.64万
• 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/10930519
• 关键词: Affect; Age related macular degeneration; Blindness; Categories; Clinical; Clinical Trials; Clinical assessments; Dark Adaptation; Darkness; Data; Detection; Disease; Disease Progression; Elderly; Eye; Fundus photography; Impairment; Investigation; Late-Onset Disorder; Measures; Mediating; Monitor; Neurodegenerative Disorders; Nonexudative age-related macular degeneration; Outcome Measure; Participant; Pathology; Patient Self-Report; Patients; Persons; Protocols documentation; Rod; Schedule; Severities; Severity of illness; Time; Vision; Vision Screening; Visual; Visual Acuity; Visual impairment; design; functional outcomes; novel; novel therapeutics; participant enrollment; retinal rods; Affect; Age related macular degeneration; Blindness; Categories; Clinical; Clinical Trials; Clinical assessments; Dark Adaptation; Darkness; Data; Detection; Disease; Disease Progression; Elderly; Eye; Fundus photography; Impairment; Investigation; Late-Onset Disorder; Measures; Mediating; Monitor; Neurodegenerative Disorders; Nonexudative age-related macular degeneration; Outcome Measure; Participant; Pathology; Patient Self-Report; Patients; Persons; Protocols documentation; Rod; Schedule; Severities; Severity of illness; Time; Vision; Vision Screening; Visual; Visual Acuity; Visual impairment; design; functional outcomes; novel; novel therapeutics; participant enrollment; 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. We have recently analyzed 4 year data and moving to analyze 5 year results.

与年龄相关的黄斑变性（AMD）是一种晚期发作的进行性神经退行性疾病，影响了全球25-300万人。 通过眼镜检查和眼底摄影进行视力筛查和临床表征是用于识别和监测AMD的传统措施。尽管它们对于表征疾病状况至关重要，但这些临床评估缺乏监测与疾病进展相关的功能视觉障碍的其他方面的敏感性，例如黑暗适应；此外，直到高级AMD之前，视力受到最小的影响。因此，需要进行功能评估，该评估有效地识别和监视疾病进展的早期迹象，这是在大幅视力丧失发作之前。这将是一个潜在的临床试验终点，以研究针对萎缩AMD患者的新疗法的潜在临床试验。这项研究的目的是确定是否可以将新的黑暗适应方案用作识别和监测AMD进程的功能结果指标。所有注册的参与者都将遵守相同的评估时间表，但根据研究入门时的疾病严重程度，他们将分为四类（0-3组）。该比较将研究ADAPTRX黑暗适应方案的敏感性和可靠性，以检测疾病严重程度不同的参与者，在5年的时间范围内检测疾病进展（作为增加的杆细胞障碍）。 我们最近分析了4年的数据并分析了5年结果。