Age-Related Eye Disease Study 2 (AREDS2) - Full Text View

Sponsor:	National Eye Institute (NEI)
Collaborator:	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

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Eye Diseases Macular Degeneration

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Lutein Zeaxanthin Sodium dehydroacetate

U.S. FDA Resources

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:	December 2012
Estimated Primary Completion Date:	December 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: Omega-3 long-chain polyunsaturated fatty acids 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 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 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

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

Sponsors and Collaborators

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

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:

AREDS2 Website This link exits the ClinicalTrials.gov site

No publications provided by National Eye Institute (NEI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hubbard LD, Danis RP, Neider MW, Thayer DW, Wabers HD, White JK, Pugliese AJ, Pugliese MF; Age-Related Eye Disease 2 Research Group. Brightness, contrast, and color balance of digital versus film retinal images in the age-related eye disease study 2. Invest Ophthalmol Vis Sci. 2008 Aug;49(8):3269-82. Epub 2008 Apr 17.

Responsible Party:	Emily Y. Chew, MD/Study Chair, National Eye Institute
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:	January 21, 2009
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 February 09, 2012