Trial record 1 of 8 for:    AREDS2
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Age-Related Eye Disease Study 2 (AREDS2)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00345176
First received: June 14, 2006
Last updated: November 1, 2013
Last verified: November 2013

June 14, 2006
November 1, 2013
September 2006
October 2012   (final data collection date for primary outcome measure)
Development of Advanced AMD in People at Moderate to High Risk for Progression. [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: No ]
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.
Progression to advanced AMD and/or moderate vision loss in people at moderate to high risk for progression.
Complete list of historical versions of study NCT00345176 on ClinicalTrials.gov Archive Site
  • Progression to Moderate Vision Loss [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: No ]
    Loss defined as >/= 3 lines of letters from baseline or treatment for choroidal neovascularization
  • Adverse Events [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: Yes ]
    Safety outcomes included serious adverse events and mortality.
  • Progression to Cataract Surgery [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: No ]
    The study examined the effects of lutein/zeaxanthin on progression to cataract surgery with data collected during regular telephone contacts and the annual study visits.
Not Provided
Not Provided
Not Provided
 
Age-Related Eye Disease Study 2 (AREDS2)
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Age-related Macular Degeneration
  • Cataract
  • Dietary Supplement: Lutein/zeaxanthin
    10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules)
  • 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
  • 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)
  • Active Comparator: Lutein/Zeaxanthin
    lutein (10mg)/zeaxanthin (2 mg)
    Intervention: Dietary Supplement: Lutein/zeaxanthin
  • Active Comparator: DHA/EPA
    DHA (350 mg)/EPA (650 mg)
    Intervention: Dietary Supplement: DHA/EPA
  • Active Comparator: Lutein/Zeaxanthin + DHA/EPA
    lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
    Intervention: Drug: Lutein/zeaxanthin and DHA/EPA
  • Placebo Comparator: Placebo/Control
    Considered control because all participants received the AREDS formulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4203
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00345176
NEI-120, N01-EY-5-0007, HHS-N-260-2005-00007-C, CC-070025, 07-EI-0025
Yes
National Eye Institute (NEI)
National Eye Institute (NEI)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Office of Dietary Supplements (ODS)
  • National Center for Complementary and Alternative Medicine (NCCAM)
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
National Eye Institute (NEI)
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP