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用于开展干性年龄相关性黄斑变性临床试验的视觉功能终点指标

Visual Function Endpoints to Enable Dry AMD Clinical Trials.

作者信息

Lesmes Luis Andres, Jackson Mary Lou, Bex Peter

机构信息

Schepens Eye Research Institute, 20 Staniford St, Boston, MA, United States.

Department of Ophthalmology, Harvard Medical School, United States.

出版信息

Drug Discov Today Ther Strateg. 2013 Spring;10(1):e43-e50. doi: 10.1016/j.ddstr.2012.11.002. Epub 2013 Feb 28.

Abstract

The slow progression of non-exudative age-related macular degeneration (dry AMD) presents challenges for drug discovery. The standard endpoint used for ophthalmic clinical trials, best-corrected visual acuity, is insensitive to the early stages and slow progression of dry AMD. Effective drug discovery for dry AMD treatments will therefore require novel applications of more effective visual function endpoints. This review will present candidates for visual function endpoints for dry AMD clinical trials. The promising visual assessments include contrast sensitivity, reading speed, microperimetry, and dark adaptation. Their adoption as exploratory endpoints in future trials will be critical for determining their accuracy, precision, and applicability, and ultimately determine their value for drug discovery.

摘要

非渗出性年龄相关性黄斑变性(干性年龄相关性黄斑变性)进展缓慢,这给药物研发带来了挑战。眼科临床试验所使用的标准终点——最佳矫正视力,对干性年龄相关性黄斑变性的早期阶段和缓慢进展并不敏感。因此,针对干性年龄相关性黄斑变性治疗的有效药物研发将需要更有效的视觉功能终点的新应用。本综述将介绍干性年龄相关性黄斑变性临床试验视觉功能终点的候选指标。有前景的视觉评估包括对比敏感度、阅读速度、微视野检查和暗适应。在未来试验中采用这些指标作为探索性终点,对于确定其准确性、精确性和适用性至关重要,并最终确定它们在药物研发中的价值。

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Visual Function Endpoints to Enable Dry AMD Clinical Trials.用于开展干性年龄相关性黄斑变性临床试验的视觉功能终点指标
Drug Discov Today Ther Strateg. 2013 Spring;10(1):e43-e50. doi: 10.1016/j.ddstr.2012.11.002. Epub 2013 Feb 28.

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本文引用的文献

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Assessment of visual performance in the evaluation of new medical products.新医疗产品评估中的视觉性能评估
Drug Discov Today Technol. 2007 Winter;4(2):55-61. doi: 10.1016/j.ddtec.2007.10.009.
3
Biomarkers and surrogate endpoints in clinical trials.生物标志物和临床试验中的替代终点。
Stat Med. 2012 Nov 10;31(25):2973-84. doi: 10.1002/sim.5403. Epub 2012 Jun 18.
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Clinical trials for glaucoma neuroprotection are not impossible.青光眼神经保护的临床试验并非不可能。
Curr Opin Ophthalmol. 2012 Mar;23(2):144-54. doi: 10.1097/ICU.0b013e32834ff490.

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