Age-Related Eye Disease Study (AREDS)

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000145

Collaborator

Bausch & Lomb Incorporated (Industry)

4,757

Enrollment

Arms

195

Duration (Months)

Study Details

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

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 :

Sep 1, 1990

Actual Primary Completion Date :

Oct 1, 2001

Actual Study Completion Date :

Dec 1, 2006

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

Progression of age-related macular degeneration []
Progression of lens opacity (cataract) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.