Trial record 1 of 1 for:    NCT00345176
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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

  Hide Study Locations
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
Shiley Eye Center - UCSD
La Jolla, California, United States, 92093
Loma Linda University
Loma Linda, California, United States, 92354
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
Doheny Eye Institute
Los Angeles, California, United States, 90033
VA Northern California Health Care System
Martinez, California, United States, 94553
Southern California Desert Retina Consultants, MC
Palm Springs, California, United States, 92262
University of California, Davis
Sacramento, California, United States, 95817
West Coast Retina Medical Group, Inc
San Francisco, California, United States, 94107
Pacific Eye Associates
San Francisco, California, United States, 94115
United States, Colorado
Colorado Retina Associates
Denver, Colorado, United States, 80218
Eldorado Retina Associates, PC
Louisville, Colorado, United States, 80027
United States, Connecticut
Yale University Eye Center
New Haven, Connecticut, United States, 06510
United States, Florida
Retina Group of Florida
Ft. Lauderdale, Florida, United States, 33334
University of Florida
Jacksonville, Florida, United States, 32209
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Georgia
Emory University Eye Center
Atlanta, Georgia, United States, 30322
Georgia Retina, PC
Decatur, Georgia, United States, 30030
United States, Illinois
The University of Illinois
Chicago, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611
NorthShore University HealthSystems
Glenview, Illinois, United States, 60026
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
Paducah Retinal Center
Paducah, Kentucky, United States, 42001
United States, Maryland
Elman Retina Group
Baltimore, Maryland, United States, 21237
Wilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
National Eye Institute
Bethesda, Maryland, United States, 20892
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
Henry Ford Health System - Eye Care Services
Detroit, Michigan, United States, 48202
Kresge Eye Institute
Detroit, Michigan, United States, 48201
Vision Research Foundation
Grand Rapids, Michigan, United States, 49546
Vision Research Foundation
Royal Oak, Michigan, United States, 48073
Vision Research Foundation
Traverse City, Michigan, United States, 49686
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
University Health Care - Mason Eye Institute
Columbia, Missouri, United States, 65212
Mid-America Retina Consultants, PA
Kansas City, Missouri, United States, 64111
Eye Foundation of Kansas City
Kansas City, Missouri, United States, 64108
The Retina Institute
St Louis, Missouri, United States, 63110
Washington University School of Medicine
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
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
New York Eye and Ear Infirmary
New York, New York, United States, 10003
Manhattan Eye, Ear and Throat Hospital
New York, New York, United States, 10021
University of Rochester Eye Institute
Rochester, New York, United States, 14642
Retina Consultants, PLLC
Slingerlands, New York, United States, 12159
The Research Foundation of SUNY/Stony Brook
Stony Brook, New York, United States, 11794
United States, North Carolina
Western Carolina Retinal Associates
Asheville, North Carolina, United States, 28803
UNC Department of Ophthalmology
Chapel Hill, North Carolina, United States, 27599
Charlotte Eye Ear Nose and Throat Associates
Charlotte, North Carolina, United States, 28210
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University Eye Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Retina Associates of Cleveland
Cleveland, Ohio, United States, 44122
Ohio State University
Columbus, Ohio, United States, 43210
Retina Associates of Cleveland
Middleburg Heights, Ohio, United States, 44130
Retina Associates of Cleveland
Youngstown, Ohio, United States, 44505
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Retina Northwest, PC
Portland, Oregon, United States, 97210
Devers Eye Institute
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pennsylvania Retina Specialists, PC
Camp Hill, Pennsylvania, United States, 17011
Penn State M.S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
Wills Eye Hospital/Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
Retina Vitreous Consultants
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Carolina Retina Center
Columbia, South Carolina, United States, 29223
Palmetto Retina Center
Columbia, South Carolina, United States, 29204
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
Arlington, Texas, United States, 76012
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Retina Associates
Dallas, Texas, United States, 75231
Baylor College of Medicine
Houston, Texas, United States, 77030
Retina Consultants of Houston
Houston, Texas, United States, 77030
Texas Retina Associates
Lubbock, Texas, United States, 79424
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
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
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 23, 2014