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
  Purpose

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.


Condition Intervention Phase
Age-related Macular Degeneration
Cataract
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

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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
Active Comparator: Lutein/Zeaxanthin
lutein (10mg)/zeaxanthin (2 mg)
Dietary Supplement: Lutein/zeaxanthin
10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules)
Active Comparator: DHA/EPA
DHA (350 mg)/EPA (650 mg)
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
Active Comparator: Lutein/Zeaxanthin + DHA/EPA
lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
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)
Placebo Comparator: Placebo/Control
Considered control because all participants received 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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345176

  Show 91 Study Locations
Sponsors and Collaborators
Investigators
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
Results First Received: November 1, 2013
Last Updated: November 1, 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 October 22, 2014