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:	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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Dietary Supplements Diets Eye Diseases Macular Degeneration

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Lutein Zeaxanthin

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
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 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.

Contacts and Locations

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

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Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Jones Eye Institute - UAMS
Little Rock, Arkansas, United States, 72205
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Southern California Desert Retina Consultants, MC
Palm Springs, California, United States, 92262
West Coast Retina Medical Group, Inc
San Francisco, California, United States, 94107
University of California, Davis
Sacramento, California, United States, 95817
Pacific Eye Associates
San Francisco, California, United States, 94115
Doheny Eye Institute
Los Angeles, California, United States, 90033
Loma Linda University
Loma Linda, California, United States, 92354
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
VA Northern California Health Care System
Martinez, California, United States, 94553
Shiley Eye Center - UCSD
La Jolla, California, United States, 92093
United States, Colorado
Eldorado Retina Associates, PC
Louisville, Colorado, United States, 80027
Centura Health Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Yale University Eye Center
New Haven, Connecticut, United States, 06510
United States, Florida
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
Retina Group of Florida
Ft. Lauderdale, Florida, United States, 33334
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
University of Florida
Jacksonville, Florida, United States, 32209
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Georgia
Emory University Eye Center
Atlanta, Georgia, United States, 30322
Georgia Retina, PC
Decatur, Georgia, United States, 30030
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Northwestern University
Chicago, Illinois, United States, 60611
The University of Illinois
Chicago, Illinois, United States, 60612
Evanston Northwestern Healthcare
Glenview, Illinois, United States, 60026
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Paducah Retinal Center
Paducah, Kentucky, United States, 42001
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
United States, Maryland
National Eye Institute
Bethesda, Maryland, United States, 20892
Wilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Elman Retina Group
Baltimore, Maryland, United States, 21237
The Retina Group of Washington
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Michigan
Vision Research Foundation
Royal Oak, Michigan, United States, 48073
Vision Research Foundation
Grand Rapids, Michigan, United States, 49546
Vision Research Foundation
Traverse City, Michigan, United States, 49686
Henry Ford Health System - Eye Care Services
Detroit, Michigan, United States, 48202
Kresge Eye Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Mid-America Retina Consultants, PA
Kansas City, Missouri, United States, 64111
Eye Foundation of Kansas City
Kansas City, Missouri, United States, 64108
University Health Care - Mason Eye Institute
Columbia, Missouri, United States, 65212
Barnes Retina Institute
St. Louis, Missouri, United States, 63110
United States, New Jersey
Delaware Valley Retina Associates
Lawrenceville, New Jersey, United States, 08648
UMDNJ
Newark, New Jersey, United States, 07103
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
The Research Foundation of SUNY/Stony Brook
Stony Brook, New York, United States, 11794
Retina Research Foundation, Inc.
Slingerlands, New York, United States, 12159
Manhattan Eye, Ear and Throat Hospital
New York, New York, United States, 10021
University of Rochester Eye Institute
Rochester, New York, United States, 14642
United States, North Carolina
Charlotte Eye Ear Nose and Throat Associates
Charlotte, North Carolina, United States, 28210
Wake Forest University Eye Center
Winston-Salem, North Carolina, United States, 27157
Western Carolina Retinal Associates
Asheville, North Carolina, United States, 28803
UNC Department of Ophthalmology
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Retina Associates of Cleveland
Cleveland, Ohio, United States, 44122
Retina Associates of Cleveland
Lakewood, Ohio, United States, 44107
Retina Associates of Cleveland
Youngstown, Ohio, United States, 44505
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Devers Eye Institute
Portland, Oregon, United States, 97210
Retina Northwest, PC
Portland, Oregon, United States, 97210
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Retina Vitreous Consultants
Pittsburgh, Pennsylvania, United States, 15213
Penn State M.S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Pennsylvania Retina Specialists, PC
Camp Hill, Pennsylvania, United States, 17011
Retina Diagnostic and Treatment Assoc., LLC
Philadelphia, Pennsylvania, United States, 19107
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Palmetto Retina Center
Columbia, South Carolina, United States, 29204
Carolina Retina Center
Columbia, South Carolina, United States, 29223
United States, Tennessee
Southeastern Retina Associates, PC
Knoxville, Tennessee, United States, 37909
University of Tennessee
Memphis, Tennessee, United States, 38163
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Retina Associates
Dallas, Texas, United States, 75231
Texas Retina Associates
Arlington, Texas, United States, 76012
Texas Retina Associates
Lubbock, Texas, United States, 79424
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
Vitreoretinal Consultants
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Utah
John Moran Eye Center
Salt Lake City, Utah, United States, 84132
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
The Retina Group of Washington
Fairfax, Virginia, United States, 22031
United States, Washington
Retina Center Northwest
Silverdale, Washington, United States, 98383
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226

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

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

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
Study First Received:	June 14, 2006
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00345176 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration