Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,203
- 试验地点
- 84
- 主要终点
- Development of Advanced AMD in People at Moderate to High Risk for Progression.
研究概览
简要总结
Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.
详细描述
AREDS2 was a randomized, double-masked, placebo-controlled, 2x2 factorial trial evaluating the risks and benefits of adding lutein (10 mg) + zeaxanthin (2 mg), DHA (350 mg) + EPA (650 mg), or both to the AREDS formulation, which consisted of vitamins C (500 mg), vitamin E (400 international units), beta carotene (15 mg), zinc (80 mg as zinc oxide), and copper (2 mg as cupric oxide) for the treatment of progression to advanced AMD. The study enrolled 4,203 participants aged 50 to 85 years, with sufficiently clear ocular media to allow accurate assessment of AMD from fundus photographs. Subjects were enrolled on the basis of the AREDS Simplified Severity Scale for defining risk categories for development of advanced age-related macular degeneration. All participants were offered additional treatment with the original AREDS formulation (now considered standard of care) and 3 variations of this formula. These are: (1) no beta-carotene; (2) lower amount of zinc (25 mg); and (3) no beta-carotene and lower amount of zinc (25 mg). Eligible participants were followed for a minimum of five years.
Multiple ancillary studies were conducted using the parent study (AREDS2) data to explore:
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Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin, zinc, and beta-carotene on cognitive function
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Outcome is measured with a battery of tests administered over the telephone at baseline, and at years 2 and 4 of the study.
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Primary outcome is the change in the composite score for the results of the cognitive function testing from baseline over time.
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Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on cardiovascular disease
a. Primary measure of cardiovascular morbidity and mortality 3. Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on the peripheral retina
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 50 and 85 years
- •Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye
排除标准
- •Ocular media not clear enough to allow good fundus photography
研究组 & 干预措施
Lutein/Zeaxanthin
lutein (10mg)/zeaxanthin (2 mg)
干预措施: Lutein/zeaxanthin (Dietary Supplement)
DHA/EPA
DHA (350 mg)/EPA (650 mg)
干预措施: DHA/EPA (Dietary Supplement)
Lutein/Zeaxanthin + DHA/EPA
lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
干预措施: Lutein/zeaxanthin and DHA/EPA (Drug)
结局指标
主要结局
Development of Advanced AMD in People at Moderate to High Risk for Progression.
时间窗: 5 years of follow-up
Defined as central geographic atrophy or retinal features of choroidal neovascularization detected on central grading of the stereoscopic fundus photographs or a history of treatment for advanced AMD after study enrollment.
次要结局
- Adverse Events(5 years of follow-up)
- Progression to Cataract Surgery(5 years of follow-up)
- Progression to Moderate Vision Loss(5 years of follow-up)