NCT00345176|CompletedPhase 3ResultsDMC
Age-Related Eye Disease Study 2 (AREDS2)
AREDS2
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · NIH
OTHER_GRANT · HHS
OTHER · NIH Clinical Center
OTHER · National Eye Institute
interventional
4,203
1 country
91
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2006
Actual (reported)June 27, 2006
Actual (reported)September 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 2012
Actual (reported)October 2012
Actual (reported)December 24, 2013
Actual (reported)Development of Advanced AMD in People at Moderate to High Risk for Progression.
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.
5 years of follow-up
Progression to Moderate Vision Loss
5 years of follow-up
Adverse Events
5 years of follow-up
Progression to Cataract Surgery
5 years of follow-up
Incident Cardiovascular Disease
5 years of follow-up
Cognition as Measured by a Telephone Battery
5 years of follow-up
Prevalence of Peripheral Changes as Measured Using OPTOS Imaging
5 years of follow-up
lutein (10mg)/zeaxanthin (2 mg)
DHA (350 mg)/EPA (650 mg)
lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules)
Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Jones Eye Institute - UAMS
Little Rock, Arkansas, 72205, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Shiley Eye Center - UCSD
La Jolla, California, 92093, United States
Loma Linda University
Loma Linda, California, 92354, United States
Doheny Eye Institute
Los Angeles, California, 90033, United States
Jules Stein Eye Institute
Los Angeles, California, 90095, United States
Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
Bhandari S, Vitale S, Agron E, Clemons TE, Chew EY; Age-Related Eye Disease Study 2 Research Group. Cataract Surgery and the Risk of Developing Late Age-Related Macular Degeneration: The Age-Related Eye Disease Study 2 Report Number 27. Ophthalmology. 2022 Apr;129(4):414-420. doi: 10.1016/j.ophtha.2021.11.014. Epub 2021 Nov 16.
Emily Y Chew, MD
National Eye Institute, National Institutes of Health
John Paul SanGiovanni, Sc.D.
National Eye Institute, National Institutes of Health
4,203 participants (actual enrollment reported by the registry).
First Submitted
June 14, 2006
First Posted
June 27, 2006
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
A Bioequivalence Study of Tobradex AF
Considered control because all participants received the AREDS formulation
10 mg lutein and 2 mg zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
VA Northern California Health Care System
Martinez, California, 94553, United States
Southern California Desert Retina Consultants, MC
Palm Springs, California, 92262, United States
University of California, Davis
Sacramento, California, 95817, United States
West Coast Retina Medical Group, Inc
San Francisco, California, 94107, United States
Pacific Eye Associates
San Francisco, California, 94115, United States
Colorado Retina Associates
Denver, Colorado, 80218, United States
Eldorado Retina Associates, PC
Louisville, Colorado, 80027, United States
Yale University Eye Center
New Haven, Connecticut, 06510, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33334, United States
University of Florida
Jacksonville, Florida, 32209, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Emory University Eye Center
Atlanta, Georgia, 30322, United States
Georgia Retina, PC
Decatur, Georgia, 30030, United States
Northwestern University
Chicago, Illinois, 60611, United States
The University of Illinois
Chicago, Illinois, 60612, United States
NorthShore University HealthSystems
Glenview, Illinois, 60026, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Elman Retina Group
Baltimore, Maryland, 21237, United States
Wilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
National Eye Institute
Bethesda, Maryland, 20892, United States
The Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Kresge Eye Institute
Detroit, Michigan, 48201, United States
Henry Ford Health System - Eye Care Services
Detroit, Michigan, 48202, United States
Vision Research Foundation
Grand Rapids, Michigan, 49546, United States
Vision Research Foundation
Royal Oak, Michigan, 48073, United States
Vision Research Foundation
Traverse City, Michigan, 49686, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University Health Care - Mason Eye Institute
Columbia, Missouri, 65212, United States
Eye Foundation of Kansas City
Kansas City, Missouri, 64108, United States
Mid-America Retina Consultants, PA
Kansas City, Missouri, 64111, United States
The Retina Institute
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648, United States
UMDNJ
Newark, New Jersey, 07103, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Manhattan Eye, Ear and Throat Hospital
New York, New York, 10021, United States
University of Rochester Eye Institute
Rochester, New York, 14642, United States
Retina Consultants, PLLC
Slingerlands, New York, 12159, United States
The Research Foundation of SUNY/Stony Brook
Stony Brook, New York, 11794, United States
Western Carolina Retinal Associates
Asheville, North Carolina, 28803, United States
UNC Department of Ophthalmology
Chapel Hill, North Carolina, 27599, United States
Charlotte Eye Ear Nose and Throat Associates
Charlotte, North Carolina, 28210, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest University Eye Center
Winston-Salem, North Carolina, 27157, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Retina Associates of Cleveland
Cleveland, Ohio, 44122, United States
Ohio State University
Columbus, Ohio, 43210, United States
Retina Associates of Cleveland
Middleburg Heights, Ohio, 44130, United States
Retina Associates of Cleveland
Youngstown, Ohio, 44505, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Devers Eye Institute
Portland, Oregon, 97210, United States
Retina Northwest, PC
Portland, Oregon, 97210, United States
Pennsylvania Retina Specialists, PC
Camp Hill, Pennsylvania, 17011, United States
Penn State M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Wills Eye Hospital/Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Retina Vitreous Consultants
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Palmetto Retina Center
Columbia, South Carolina, 29204, United States
Carolina Retina Center
Columbia, South Carolina, 29223, United States
Southeastern Retina Associates, PC
Knoxville, Tennessee, 37909, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
Texas Retina Associates
Lubbock, Texas, 79424, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
John Moran Eye Center
Salt Lake City, Utah, 84132, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
The Retina Group of Washington
Fairfax, Virginia, 22031, United States
Retina Center Northwest
Silverdale, Washington, 98383, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Keenan TD, Agron E, Mares JA, Clemons TE, van Asten F, Swaroop A, Chew EY; AREDS and AREDS2 Research Groups. Adherence to a Mediterranean diet and cognitive function in the Age-Related Eye Disease Studies 1 & 2. Alzheimers Dement. 2020 Jun;16(6):831-842. doi: 10.1002/alz.12077. Epub 2020 Apr 13.
Chew EY, Clemons TE, Agron E, Launer LJ, Grodstein F, Bernstein PS; Age-Related Eye Disease Study 2 (AREDS2) Research Group. Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or Other Nutrient Supplementation on Cognitive Function: The AREDS2 Randomized Clinical Trial. JAMA. 2015 Aug 25;314(8):791-801. doi: 10.1001/jama.2015.9677.
Writing Group for the AREDS2 Research Group; Bonds DE, Harrington M, Worrall BB, Bertoni AG, Eaton CB, Hsia J, Robinson J, Clemons TE, Fine LJ, Chew EY. Effect of long-chain omega-3 fatty acids and lutein + zeaxanthin supplements on cardiovascular outcomes: results of the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA Intern Med. 2014 May;174(5):763-71. doi: 10.1001/jamainternmed.2014.328.
Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
Domalpally A, Danis RP, Chew EY, Clemons TE, Reed S, Sangiovanni JP, Ferris FL 3rd; Age-Related Eye Disease Study 2 Research Group. Evaluation of optimized digital fundus reflex photographs for lens opacities in the age-related eye disease study 2: AREDS2 report 7. Invest Ophthalmol Vis Sci. 2013 Sep 5;54(9):5989-94. doi: 10.1167/iovs.13-12301.
Toy BC, Krishnadev N, Indaram M, Cunningham D, Cukras CA, Chew EY, Wong WT. Drusen regression is associated with local changes in fundus autofluorescence in intermediate age-related macular degeneration. Am J Ophthalmol. 2013 Sep;156(3):532-542.e1. doi: 10.1016/j.ajo.2013.04.031. Epub 2013 Jul 3.
Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, SanGiovanni JP, Ferris FL, Wong WT, Agron E, Clemons TE, Sperduto R, Danis R, Chandra SR, Blodi BA, Domalpally A, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Friberg TR, Rosenfeld PJ, Toth CA, Bernstein P. Lutein/zeaxanthin for the treatment of age-related cataract: AREDS2 randomized trial report no. 4. JAMA Ophthalmol. 2013 Jul;131(7):843-50. doi: 10.1001/jamaophthalmol.2013.4412.
Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013 May 15;309(19):2005-15. doi: 10.1001/jama.2013.4997.
Danis RP, Domalpally A, Chew EY, Clemons TE, Armstrong J, SanGiovanni JP, Ferris FL 3rd; AREDS2 Study Group. Methods and reproducibility of grading optimized digital color fundus photographs in the Age-Related Eye Disease Study 2 (AREDS2 Report Number 2). Invest Ophthalmol Vis Sci. 2013 Jul 8;54(7):4548-54. doi: 10.1167/iovs.13-11804.
Bernstein PS, Ahmed F, Liu A, Allman S, Sheng X, Sharifzadeh M, Ermakov I, Gellermann W. Macular pigment imaging in AREDS2 participants: an ancillary study of AREDS2 subjects enrolled at the Moran Eye Center. Invest Ophthalmol Vis Sci. 2012 Sep 14;53(10):6178-86. doi: 10.1167/iovs.12-10275.
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. doi: 10.1167/iovs.07-1267. Epub 2008 Apr 17.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
May 5, 2015
Results First Posted
December 24, 2013
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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