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Trial record 1 of 1 for:    NCT00345176
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Age-Related Eye Disease Study 2 (AREDS2) (AREDS2)

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ClinicalTrials.gov Identifier: NCT00345176
Recruitment Status : Completed
First Posted : June 27, 2006
Results First Posted : December 24, 2013
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Age-related Macular Degeneration Cataract Dietary Supplement: Lutein/zeaxanthin Dietary Supplement: DHA/EPA Drug: Lutein/zeaxanthin and DHA/EPA Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2006
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Development of Advanced AMD in People at Moderate to High Risk for Progression. [ Time Frame: 5 years of follow-up ]
    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 :
  1. Progression to Moderate Vision Loss [ Time Frame: 5 years of follow-up ]
    Loss defined as >/= 3 lines of letters from baseline or treatment for choroidal neovascularization

  2. Adverse Events [ Time Frame: 5 years of follow-up ]
    Safety outcomes included serious adverse events and mortality.

  3. Progression to Cataract Surgery [ Time Frame: 5 years of follow-up ]
    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.


Other Outcome Measures:
  1. Incident Cardiovascular Disease [ Time Frame: 5 years of follow-up ]
    Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on cardiovascular disease

  2. Cognition as Measured by a Telephone Battery [ Time Frame: 5 years of follow-up ]
    Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin, zinc, and beta-carotene on cognitive function

  3. Prevalence of Peripheral Changes as Measured Using OPTOS Imaging [ Time Frame: 5 years of follow-up ]
    Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on the peripheral retina

  4. Genetics for the Association of AMD and Cataract [ Time Frame: 5 years of follow-up ]
  5. Genetics for the Progression of AMD and Cataract [ Time Frame: 5 years of follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345176


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Sponsors and Collaborators
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
National Center for Complementary and Integrative Health (NCCIH)
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:
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 ( Other Grant/Funding Number: NIH )
HHS-N-260-2005-00007-C ( Other Grant/Funding Number: HHS )
CC-070025 ( Other Identifier: NIH Clinical Center )
07-EI-0025 ( Other Identifier: National Eye Institute )
First Posted: June 27, 2006    Key Record Dates
Results First Posted: December 24, 2013
Last Update Posted: May 5, 2015
Last Verified: April 2015

Keywords provided by National Eye Institute (NEI):
age-related macular degeneration
AMD
lutein
zeaxanthin
docosahexaenoic acid
eicosapentaenoic acid

Additional relevant MeSH terms:
Macular Degeneration
Cataract
Eye Diseases
Retinal Degeneration
Retinal Diseases
Lens Diseases