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Age-Related Eye Disease Study (AREDS)

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ClinicalTrials.gov Identifier: NCT00000145
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : January 23, 2009
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
National Eye Institute (NEI)

Tracking Information
First Submitted Date  ICMJE September 23, 1999
First Posted Date  ICMJE September 24, 1999
Last Update Posted Date January 23, 2009
Study Start Date  ICMJE September 1990
Actual Primary Completion Date October 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
  • Progression of age-related macular degeneration
  • Progression of lens opacity (cataract)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Age-Related Eye Disease Study (AREDS)
Official Title  ICMJE Age-Related Eye Disease Study (AREDS)
Brief Summary

To assess the clinical course, prognosis, and risk factors of age-related macular degeneration (AMD) and cataract.

To evaluate, in randomized clinical trials, the effects of pharmacologic doses of (1) antioxidants and zinc on the progression of AMD and (2) antioxidants on the development and progression of lens opacities.
Detailed Description

AMD and cataract are the leading causes of visual impairment and blindness in the United States. Based on many clinical studies, it is apparent that the frequency of both diseases increases dramatically after age 60. Although excellent treatments for cataract are available, there are no equivalent treatments for AMD. As the average lifespan of our population increases, the number of people who develop AMD will increase dramatically in the years ahead. Unless successful means of prevention or treatment are developed, blindness from AMD -- and its importance as a public health problem -- will increase.

Neither the etiology nor the natural history of AMD or cataract is known. Epidemiologic studies suggest that a number of risk factors may be associated with AMD and cataract, but the strength of the evidence in support of these hypotheses varies. Possibly associated with AMD are personal characteristics, such as age, race, height, family history, and strength of hand grip; ocular characteristics, such as hyperopia and color of iris; and cardiovascular diseases, smoking, lung infections, and chemical exposures. Clinical and laboratory studies suggest the following factors may be associated with progression of AMD: drusen type, choroidal vascular diseases, and photic injury.

Epidemiologic studies of cataract suggest that associated risk factors may include personal characteristics, such as age, sex, race, occupation, and educational status; ocular characteristics, such as iris color; and diabetes mellitus, hypertension, drug exposure, smoking, and sunlight exposure. Animal studies and observational epidemiologic studies suggest that deficiencies in vitamins C and E, carotenoids, and the trace elements zinc and selenium also may be associated with the development of the two diseases, especially cataract. Although surgical treatment to remove cataract is very effective, cataract surgery carries risks, as does any other surgery. Therefore, many research efforts focus on preventing or slowing cataract development, as well as on determining the causes of cataract formation.

The Age-Related Eye Disease Study (AREDS) is a major research program to improve our understanding of the predisposing factors, clinical course, and prognostic factors of AMD and cataract. Eligible patients are randomized to treatment with placebo, antioxidants, zinc, or antioxidants plus zinc, and are followed for a minimum of 5 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Degeneration
  • Cataract
  • Lens Opacities
Intervention  ICMJE
  • Dietary Supplement: Antioxidants
    500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene
  • Dietary Supplement: Zinc
    80 milligrams zinc oxide; 2 milligrams of cupric oxide
  • Dietary Supplement: Antioxidants and zinc
    500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide
Study Arms  ICMJE
  • Experimental: 1
    Antioxidants
    Intervention: Dietary Supplement: Antioxidants
  • Experimental: 2
    Zinc
    Intervention: Dietary Supplement: Zinc
  • Experimental: 3
    Antioxidants and zinc
    Intervention: Dietary Supplement: Antioxidants and zinc
  • No Intervention: 4
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2009)		 4757
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date October 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Men and women between the ages of 55 and 80 years whose macular status ranges from no evidence of AMD in either eye to relatively severe disease with vision loss in one eye but good vision in the fellow eye (20/30 or better) are eligible for the study provided that their ocular media are clear enough to allow good fundus photography.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000145
Other Study ID Numbers  ICMJE NEI-44
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party John Paul SanGiovanni, Sc.D., National Eye Institute
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE National Eye Institute (NEI)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bausch & Lomb Incorporated
Investigators  ICMJE
Principal Investigator: Emily Y. Chew, MD National Eye Institute (NEI)
PRS Account National Eye Institute (NEI)
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP