Age-Related Eye Disease Study 2 (AREDS2)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Age-related Macular Degeneration |
Dietary Supplement: Lutein/zeaxanthin Dietary Supplement: DHA/EPA Drug: Lutein/zeaxanthin and DHA/EPA |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- 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 ]
- 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 ]
| Enrollment: | 4203 |
| Study Start Date: | September 2006 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Progression to Advanced AMD for lutein/zeaxanthin alone versus placebo
|
Dietary Supplement: Lutein/zeaxanthin
10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules)
|
|
Placebo Comparator: 2
Progression to Advanced AMD for DHA/EPA alone versus placebo
|
Dietary Supplement: DHA/EPA
Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
Other Name: docosahexaenoic acid; eicosapentaenoic acid
|
|
Placebo Comparator: 3
Progression to Advanced AMD for lutein/zeaxanthin and DHA/EPA versus placebo
|
Drug: Lutein/zeaxanthin and DHA/EPA
10 mg lutein and 2 mg zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
|
Detailed Description:
AREDS2 is a multi-center randomized trial of approximately 4,200 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 enrolled 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 are 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 are followed for a minimum of five years.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Ocular media not clear enough to allow good fundus photography
Contacts and Locations
Show 91 Study Locations| Study Chair: | Emily Y Chew, MD | National Eye Institute, National Institutes of Health |
| Study Director: | John Paul SanGiovanni, Sc.D. | National Eye Institute, National Institutes of Health |
More Information
Additional Information:
No publications provided by National Eye Institute (NEI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Eye Institute (NEI) |
| ClinicalTrials.gov Identifier: | NCT00345176 History of Changes |
| Obsolete Identifiers: | NCT00409513 |
| Other Study ID Numbers: | NEI-120, N01-EY-5-0007, HHS-N-260-2005-00007-C, CC-070025, 07-EI-0025 |
| Study First Received: | June 14, 2006 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by National Eye Institute (NEI):
|
age-related macular degeneration AMD lutein |
zeaxanthin docosahexaenoic acid eicosapentaenoic acid |
Additional relevant MeSH terms:
|
Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013