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Age-Related Eye Disease Study (AREDS)

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00000145
First received: September 23, 1999
Last updated: January 21, 2009
Last verified: January 2009

September 23, 1999
January 21, 2009
September 1990
October 2001   (final data collection date for primary outcome measure)
  • Progression of age-related macular degeneration [ Designated as safety issue: No ]
  • Progression of lens opacity (cataract) [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00000145 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Age-Related Eye Disease Study (AREDS)
Age-Related Eye Disease Study (AREDS)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Macular Degeneration
  • Cataract
  • Lens Opacities
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4757
December 2006
October 2001   (final data collection date for primary outcome measure)
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.
Both
55 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00000145
NEI-44
Yes
Not Provided
Not Provided
John Paul SanGiovanni, Sc.D., National Eye Institute
National Eye Institute (NEI)
Bausch & Lomb Incorporated
Principal Investigator: Emily Y. Chew, MD National Eye Institute (NEI)
National Eye Institute (NEI)
January 2009

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