NEI Clinical Studies
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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.
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.
Patient Recruitment Status
Completed. Patient recruitment began in September 1990. The first participant was enrolled November 1992, and recruitment ended in July 1995 for all but minority participants. The last participant was enrolled January 1998. A total of 4,757 participants were enrolled.
Current Status of Study
AREDS researchers found that people at high risk of developing advanced stages of AMD lowered their risk by about 25 percent when treated with a high-dose combination of vitamin C, vitamin E, beta-carotene, and zinc. In the same high risk group -- which includes people with intermediate AMD, or advanced AMD in one eye but not the other eye -- the nutrients reduced the risk of vision loss caused by advanced AMD by about 19 percent. For those study participants who had either no AMD or early AMD, the supplements did not provide an apparent benefit.
In the cataract portion of the study, researchers discovered that the same nutrients had no significant effect on the development or progression of age-related cataract.
McBee WL, and the AREDS Research Group: A program designed to provide and maintain training in a large long-term clinical trial. Controlled Clinical Trials 22(25): 865, 2001.
The Age-Related Eye Disease Research Group: A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related cataract and vision loss. AREDS Report No. 9. Arch Ophthalmol 119: 1439-1452, 2001.
The Age-Related Eye Disease Research Group: A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss. AREDS Report No. 8. Arch Ophthalmol 119: 1417-1436, 2001.
Lindblad AS, and the AREDS Research Group: Incorporating a cognitive function ancillary study in an ophthalmic clinical trial. Controlled Clinical Trials 22(25): 625, 2001.
The Age-Related Eye Disease Research Group: Risk factors associated with age-related nuclear and cortical cataract. A case-control study in the Age-Related Eye Disease Study. AREDS Report No. 5. Ophthalmology 108: 1400-1408, 2001.
The Age-Related Eye Disease Research Group: The effect of five-year zinc supplementation on serum zinc, serum cholesterol, and hematocrit. A randomized comparison in the Age-Related Eye Disease Study. AREDS Report No. 7. Journal of Nutrition Accepted, 2001.
The Age-Related Eye Disease Research Group: The Age-Related Eye Disease Study (AREDS) system for classifying cataracts from photographs. AREDS Report No. 4. Am J Ophthalmol 131: 167-175, 2001.
The Age-Related Eye Disease Research Group: The Age-Related Eye Disease Study (AREDS) system for classifying age-related macular degeneration from stereoscopic color fundus photographs. AREDS Report No.6. Am J Ophthalmol 132: 668-681, 2001.
The Age-Related Eye Disease Research Group: The Age-Related Eye Disease Study (AREDS): A clinical trial of zinc and antioxidants. AREDS Report 2. J of Nutrition 130: 1516S-1519S, 2000.
The Age-Related Eye Disease Research Group: The Age-Related Eye Disease Study (AREDS): Risk factors associated with age-related macular degeneration. AREDS Report No. 3. Ophthalmology 107: 2224-2232, 2000.
The Age-Related Eye Disease Research Group: The Age-Related Eye Disease Study (AREDS): Design implications. AREDS Report No. 1. Controlled Clinical Trials 20: 573-600, 1999.
Ansay SE, Armstrong JR, Osterby KR, Reimers JL, Badal DR, Geithman PL, Miner KD, King WN, The Age-Related Eye Disease Study (AREDS) Research Group: Evaluation of cortical and PSC lens opacities from fundus camera reflex photographs. Abstract, Annual Meeting. Association for Research in Vision and Ophthalmology (ARVO), Fort Lauderdale, Florida May 11-16, 1997.
Gensler GR, Lindblad AS, Age-Related Eye Disease Study (AREDS) Research Group: Evaluation of a two-phase enrollment design: Experience of the Age-Related Eye Disease Study. Abstract, 2nd Joint Meeting, Society for Clinical Trials and International Society for Clinical Biostatistics, Boston, Massachusetts, July 6-10, 1997.
Magli YL, Klein BEK, Sperduto RD, Hubbard LD, Neider MW, King WN, Davis MD: Age-Related Eye Disease Study (AREDS) Research Group extension of the Wisconsin Lens Opacity Grading System: Abstract, Annual Meeting. Association for Research in Vision and Ophthalmology (ARVO), Fort Lauderdale, Florida May 11-16, 1997.
Sperduto RD, Ferris III FL, Kurinij N: Do we have a nutritional treatment for age-related cataract or macular degeneration?. Arch Ophthalmol 108: 1403-1405, 1990.
Anne Sowell, Ph.D.
Dayton Miller, Ph.D.
Nutritional Biochemistry Branch
Centers for Disease Control and Prevention
Frederick L. Ferris III, M.D.
Emily Y. Chew, M.D.
Robert Sperduto, M.D.
National Eye Institute
National Institutes of Health
Building 31, Room 6A52
31 Center Drive MSC 2510
Bethesda, MD 20892-2510
Telephone: (301) 496-6583
Fax: (301) 496-2297
Anne S. Lindblad, Ph.D.
Fred Ederer, M.A., F.A.C.E.
The EMMES Corporation
401 North Washington Street, Suite 700
Rockville, MD 20850
Telephone: (301) 251-1161
Fax: (301) 251-1355
Nutrition Coordinating Center
University of Minnesota
Division of Epidemiology
School of Public Health
Matthew D. Davis, M.D.
Barbara E. K. Klein, M.D.
Ronald Klein, M.D.
University of Wisconsin - Madison
Department of Ophthalmology & Visual Sciences
Natalie Kurinij, Ph.D
National Eye Institute
National Institutes of Health
Executive Plaza South, Suite 350
6120 Executive Boulevard, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-5983
Fax: (301) 402-0528
Last Updated: 2/4/2002