The Age-Related Eye Disease Study 2 (AREDS2)

年龄相关眼病研究 2 (AREDS2)

• 批准号: 8339797
• 负责人: Wai Wong
• 金额: $ 6.56万
• 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/8339797
• 关键词: Age related macular degeneration; Beta Carotene; Bilateral; Blindness; Cataract; Clinical; Clinical Trials Design; Data; Development; Dose; Drug Formulations; Drusen; Elderly; Enrollment; Evaluation; Exudative age-related macular degeneration; Eye; Eye diseases; Fundus; Goals; Letters; Lutein; National Eye Institute; Nutrient; Omega-3 Fatty Acids; Oral; Participant; Phase; Randomized Clinical Trials; Risk Factors; Supplementation; Time; United States National Institutes of Health; Visual; Xanthophylls; Zinc; age related; aged; base; geographic atrophy; lens; macula; outcome forecast; zeaxanthin

The primary objective of AREDS2 is to evaluate the effect of dietary xanthophylls (lutein/zeaxanthin) and/or omega-3 LCPUFAs (DHA and EPA) on progression to advanced AMD. This objective will be accomplished by collecting and assessing the data on approximately 4,000 AREDS2 participants aged 50 to 85 years (of which 65 participants are from the NIH center), who at the time of enrollment, have sufficiently clear lenses for quality fundus photographs and have either: 1) bilateral large drusen or 2) large drusen in one eye and advanced AMD (neovascular AMD or central geographic atrophy) in the fellow eye. The objectives of AREDS2 are to: 1. Study the effects of high supplemental doses of the dietary xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs (DHA and EPA) on the development of advanced AMD. 2. Study the effects of these supplements on moderate vision loss (doubling of the visual angle or the loss of 15 or more letters on the ETDRS chart). 3. Study the effects of these supplements on cataract. 4. Study the effects of eliminating beta-carotene in the original AREDS formulation on the development and progression of AMD. 5. Study the effects of reducing zinc in the original AREDS formulation on the development and progression of AMD. 6. Validate the fundus photographic AMD scale developed from the Age-Related Eye Disease Study.

AREDS 2的主要目的是评估膳食叶黄素（叶黄素/玉米黄质）和/或ω-3 LCPUFA（DHA和EPA）对进展为晚期AMD的影响。 这一目标将通过收集和评估约4，000名年龄在50至85岁之间的AREDS 2参与者的数据来实现（其中65名参与者来自NIH中心），在入组时，具有足够清晰的镜片以拍摄高质量的眼底照片，并且：1）双侧大玻璃疣或2）一只眼睛中的大玻璃疣和对侧眼睛中的晚期AMD（新生血管性AMD或中央地图状萎缩）。 AREDS 2的目标是： 1. 研究高剂量补充膳食叶黄素（叶黄素和玉米黄质）和omega-3 LCPUFA（DHA和EPA）对晚期AMD发展的影响。 2. 研究这些补充剂对中度视力丧失的影响（视角加倍或ETDRS图表上15个或更多字母的损失）。 3. 研究这些补充剂对白内障的影响。 4. 研究消除原始AREDS制剂中的β-胡萝卜素对AMD发展和进展的影响。 5. 研究减少原始AREDS制剂中的锌对AMD的发展和进展的影响。 6. 根据AMD相关眼病研究开发的眼底照相AMD量表。