Age-Related Eye Disease Study 2 (AREDS2) (AREDS2)
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ClinicalTrials.gov Identifier: NCT00345176 |
Recruitment Status :
Completed
First Posted : June 27, 2006
Results First Posted : December 24, 2013
Last Update Posted : May 5, 2015
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Tracking Information | |||||||
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First Submitted Date ICMJE | June 14, 2006 | ||||||
First Posted Date ICMJE | June 27, 2006 | ||||||
Results First Submitted Date ICMJE | November 1, 2013 | ||||||
Results First Posted Date ICMJE | December 24, 2013 | ||||||
Last Update Posted Date | May 5, 2015 | ||||||
Study Start Date ICMJE | September 2006 | ||||||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Development of Advanced AMD in People at Moderate to High Risk for Progression. [ Time Frame: 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.
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Original Primary Outcome Measures ICMJE |
Progression to advanced AMD and/or moderate vision loss in people at moderate to high risk for progression. | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Age-Related Eye Disease Study 2 (AREDS2) | ||||||
Official Title ICMJE | 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 | 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. | ||||||
Detailed Description | 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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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
4203 | ||||||
Original Enrollment ICMJE |
4000 | ||||||
Actual Study Completion Date ICMJE | October 2012 | ||||||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00345176 | ||||||
Other Study ID Numbers ICMJE | NEI-120 N01-EY-5-0007 ( Other Grant/Funding Number: NIH ) HHS-N-260-2005-00007-C ( Other Grant/Funding Number: HHS ) CC-070025 ( Other Identifier: NIH Clinical Center ) 07-EI-0025 ( Other Identifier: National Eye Institute ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | National Eye Institute (NEI) | ||||||
Original Responsible Party | Not Provided | ||||||
Current Study Sponsor ICMJE | National Eye Institute (NEI) | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | National Eye Institute (NEI) | ||||||
Verification Date | April 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |