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Age-Related Eye Disease Study 2 (AREDS2)

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00345176
  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: Omega-3 long-chain polyunsaturated fatty acids
Drug: Lutein/zeaxanthin and Omega-3 long-chain polyunsaturated fatty acids
Phase III

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Dietary Supplements    Eye Diseases    Macular Degeneration   

Drug Information available for:   Lutein    Zeaxanthin    Docosahexaenoic acids    Eicosapentaenoic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

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

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment:   4000
Study Start Date:   September 2006
Estimated Study Completion Date:   June 2013
Estimated Primary Completion Date:   June 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Placebo Comparator
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)
2: Placebo Comparator
Progression to Advanced AMD for DHA/EPA alone versus placebo
Dietary Supplement: Omega-3 long-chain polyunsaturated fatty acids
Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
3: Placebo Comparator
Progression to Advanced AMD for lutein/zeaxanthin and DHA/EPA versus placebo
Drug: Lutein/zeaxanthin and Omega-3 long-chain polyunsaturated fatty acids
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 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.

  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

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

Show 90 study locations  Show 90 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


NEI Clinical Studies Database  This link exits the ClinicalTrials.gov site
 
AREDS2 Website  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Responsible Party:   National Eye Institute ( Emily Y. Chew, MD/Study Chair )
Study ID Numbers:   NEI-120, N01-EY-5-0007, HHS-N-260-2005-00007-C, CC-070025, 07-EI-0025
First Received:   June 14, 2006
Last Updated:   July 30, 2008
ClinicalTrials.gov Identifier:   NCT00345176
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

Study placed in the following topic categories:
Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on November 19, 2008




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