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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
  Purpose

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 Intervention Phase
Macular Degeneration
Cataract
Lens Opacities
Dietary Supplement: Antioxidants
Dietary Supplement: Zinc
Dietary Supplement: Antioxidants and zinc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Age-Related Eye Disease Study (AREDS)

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • Progression of age-related macular degeneration [ Designated as safety issue: No ]
  • Progression of lens opacity (cataract) [ Designated as safety issue: No ]

Enrollment: 4757
Study Start Date: September 1990
Study Completion Date: December 2006
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 23, 1999
Last Updated: January 21, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on December 02, 2016