| Descriptive Information Fields | |||||||||
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| Brief Title † | Age-Related Eye Disease Study 2 (AREDS2) | ||||||||
| Official Title † | 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 | ||||||||
| Brief Summary | To evaluate the effect of the two dietary xanthophylls (lutein and zeaxanthin) that accumulate in macula and two omega-3 long-chain polyunsaturated fatty acids (LCPUFAs), docosahexaenoic acid and eicosapentaenoic acid, on progression to advanced age-related macular degeneration (AMD) and/or moderate vision loss in people at moderate to high risk for progression. To evaluate the effects of eliminating beta-carotene from the original AREDS formulation on the development and progression of AMD. To evaluate the effects of reducing zinc in the original AREDS formulation on the development and progression of AMD. To contribute data for validation of the photographic AMD scales developed from the Age-Related Eye Disease Study. |
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| Detailed Description | AREDS2 is a multi-center randomized trial of 4,000 participants designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs (DHA and EPA) for the treatment of AMD and cataract. AREDS2 was designed to evaluate the effects of high supplemental doses of lutein and zeaxanthin and omega-3 LCPUFAs on the development of advanced AMD. The study will enroll participants aged 50 to 85 years, with sufficiently clear ocular media to allow accurate assessment of AMD from fundus photographs. Subjects will be enrolled on the basis of the AREDS Simplified Severity Scale for defining risk categories for development of advanced age-related macular degeneration. All participants will be 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 amounts of zinc; and (3) no beta-carotene and lower amounts of zinc. Eligible participants will be followed for a minimum of five years. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Progression to advanced AMD in people at moderate to high risk for progression. [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Progression to moderate vision loss [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: No ] Adverse Events [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: Yes ] Progression of lens opacity or incidence of cataract surgery [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: No ] Effect of study supplements on cognitive function [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: No ] Effect of DHA/EPA on cardiovascular morbidity and mortality [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: No ] |
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| Condition † | Age-Related Macular Degeneration | ||||||||
| Intervention † | Dietary Supplement: Lutein/zeaxanthin Dietary Supplement: Omega-3 long-chain polyunsaturated fatty acids Drug: Lutein/zeaxanthin and Omega-3 long-chain polyunsaturated fatty acids |
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| MEDLINE PMIDs | |||||||||
| Links | NEI Clinical Studies Database  AREDS2 Website |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 4000 | ||||||||
| Start Date † | September 2006 | ||||||||
| Completion Date | June 2013 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00345176 | ||||||||
| Organization ID | NEI-120 | ||||||||
| Secondary IDs †† | N01-EY-5-0007, HHS-N-260-2005-00007-C, CC-070025, 07-EI-0025 | ||||||||
| Study Sponsor † | National Eye Institute (NEI) | ||||||||
| Collaborators †† | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators † |
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| Information Provided By | National Eye Institute (NEI) | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | June 14, 2006 | ||||||||
| Last Updated Date | July 30, 2008 | ||||||||
