Not Signed In -
Zinc Sulfate Injection |
Zinca-Pak |
Clinical Trial: Age-Related Eye Disease Study (AREDS)
This study is no longer recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Macular Degeneration Cataract Lens Opacities | Drug: Antioxidants Drug: Zinc | Phase III |
MedlinePlus related topics: Cataract; Macular Degeneration
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control, Efficacy Study
Study start: September 1990
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 - 80 Years, Genders Eligible for Study: Both
Criteria
More Information
AREDS Press Release October 12, 2001
Publications
Sperduto RD, Ferris FL 3rd, Kurinij N. Do we have a nutritional treatment for age-related cataract or macular degeneration? Arch Ophthalmol. 1990 Oct;108(10):1403-5. No abstract available.
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 1997;May 11-16
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, 1997;July 6-10
[No authors listed] The effect of five-year zinc supplementation on serum zinc, serum cholesterol and hematocrit in persons randomly assigned to treatment group in the age-related eye disease study: AREDS Report No. 7. J Nutr. 2002 Apr;132(4):697-702.
[No authors listed] The Age-Related Eye Disease Study system for classifying age-related macular degeneration from stereoscopic color fundus photographs: the Age-Related Eye Disease Study Report Number 6. Am J Ophthalmol. 2001 Nov;132(5):668-81.
[No authors listed] 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. 2001 Aug;108(8):1400-8.
[No authors listed] The age-related eye disease study (AREDS) system for classifying cataracts from photographs: AREDS report no. 4. Am J Ophthalmol. 2001 Feb;131(2):167-75.
[No authors listed] Risk factors associated with age-related macular degeneration. A case-control study in the age-related eye disease study: age-related eye disease study report number 3. Age-Related Eye Disease Study Research Group. Ophthalmology. 2000 Dec;107(12):2224-32.
[No authors listed] The age-related eye disease study: a clinical trial of zinc and antioxidants-age-related eye disease study report no. 2. J Nutr. 2000 May;130(5S Suppl):1516S-9S.
[No authors listed] The Age-Related Eye Disease Study (AREDS): design implications AREDS report no. 1. The Age-Related Eye Disease Study Research Group. Control Clin Trials. 1999 Dec;20(6):573-600.
[No authors listed] A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss: AREDS report no. 9. Arch Ophthalmol. 2001 Oct;119(10):1439-52.
[No authors listed] 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. 2001 Oct;119(10):1417-36.
Record last reviewed: June 2002
Last Updated: October 13, 2004
Record first received: September 23, 1999
ClinicalTrials.gov Identifier: NCT00000145
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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