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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:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Macular Degeneration Cataract Lens Opacities Dietary Supplement: Antioxidants Dietary Supplement: Zinc Dietary Supplement: Antioxidants and zinc Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4757 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Age-Related Eye Disease Study (AREDS)
Study Start Date : September 1990
Primary Completion Date : October 2001
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Antioxidants
Dietary Supplement: Antioxidants
500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene
Experimental: 2
Zinc
Dietary Supplement: Zinc
80 milligrams zinc oxide; 2 milligrams of cupric oxide
Experimental: 3
Antioxidants and zinc
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
No Intervention: 4


Outcome Measures

Primary Outcome Measures :
  1. Progression of age-related macular degeneration
  2. Progression of lens opacity (cataract)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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.
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): NCT00000145


Sponsors and Collaborators
National Eye Institute (NEI)
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Emily Y. Chew, MD National Eye Institute (NEI)
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Paul SanGiovanni, Sc.D., National Eye Institute
ClinicalTrials.gov Identifier: NCT00000145     History of Changes
Obsolete Identifiers: NCT00001312
Other Study ID Numbers: NEI-44
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: January 23, 2009
Last Verified: January 2009

Keywords provided by National Eye Institute (NEI):
Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Cataract
Eye Diseases
Retinal Degeneration
Retinal Diseases
Lens Diseases
Zinc
Antioxidants
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents