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: April 30, 2013
Last verified: April 2013
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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: 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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
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 ]
| 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 |
|---|---|
|
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: DHA/EPA
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 DHA/EPA
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
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| 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 | |
| Doheny Eye Institute | |
| Los Angeles, California, United States, 90033 | |
| Jules Stein Eye Institute | |
| Los Angeles, California, United States, 90095 | |
| 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 | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| The University of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| 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 | |
| Kresge Eye Institute | |
| Detroit, Michigan, United States, 48201 | |
| Henry Ford Health System - Eye Care Services | |
| Detroit, Michigan, United States, 48202 | |
| 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 | |
| Manhattan Eye, Ear and Throat Hospital | |
| New York, New York, United States, 10021 | |
| New York Eye and Ear Infirmary | |
| New York, New York, United States, 10003 | |
| 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 | |
| Retina Associates of Cleveland | |
| Cleveland, Ohio, United States, 44122 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| 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 | |
| Devers Eye Institute | |
| Portland, Oregon, United States, 97210 | |
| Retina Northwest, PC | |
| 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 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Retina Vitreous Consultants | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| 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 | |
| Arlington, Texas, United States, 76012 | |
| Texas Retina Associates | |
| Dallas, Texas, United States, 75231 | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Retina Consultants of Houston | |
| Houston, Texas, United States, 77030 | |
| Baylor College of Medicine | |
| 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 |
| Last Updated: | April 30, 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 May 16, 2013