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Trial NCT00000145

Resource URI: http://static.linkedct.org/resource/trials/NCT00000145
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/1812>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/23324>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/24671>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/27240>
linkedct:brief_title Age-Related Eye Disease Study (AREDS)
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/680>
linkedct:condition <http://static.linkedct.org/resource/condition/2367>
linkedct:condition <http://static.linkedct.org/resource/condition/7197>
linkedct:condition <http://static.linkedct.org/resource/condition/7633>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 80 Years
linkedct:eligibility_minimum_age 55 Years
linkedct:end_date December 2006
linkedct:enrollment 4757 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:has_dmc Yes
linkedct:id NCT00000145
linkedct:intervention <http://static.linkedct.org/resource/intervention/122252>
linkedct:intervention <http://static.linkedct.org/resource/intervention/67591>
linkedct:intervention <http://static.linkedct.org/resource/intervention/67594>
rdfs:label Trial NCT00000145
linkedct:lastchanged_date January 21, 2009
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:nct_id NCT00000145
linkedct:number_of_arms 4 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Age-Related Eye Disease Study (AREDS)
linkedct:org_study_id NEI-44
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/16441>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000145>
linkedct:phase Phase 3
linkedct:primary_completion_date October 2001
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16958>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16963>
linkedct:reference <http://static.linkedct.org/resource/reference/11715>
linkedct:reference <http://static.linkedct.org/resource/reference/16325>
linkedct:reference <http://static.linkedct.org/resource/reference/19931>
linkedct:reference <http://static.linkedct.org/resource/reference/27814>
linkedct:reference <http://static.linkedct.org/resource/reference/28431>
linkedct:reference <http://static.linkedct.org/resource/reference/29112>
linkedct:reference <http://static.linkedct.org/resource/reference/29116>
linkedct:reference <http://static.linkedct.org/resource/reference/38524>
linkedct:reference <http://static.linkedct.org/resource/reference/5919>
linkedct:reference <http://static.linkedct.org/resource/reference/9408>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/2229>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/2365>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/2521>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/2574>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/2575>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/2740>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/3820>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/4228>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/4602>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/5871>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/6255>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/7243>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/7610>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/7993>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/8665>
linkedct:source National Eye Institute (NEI)
linkedct:start_date September 1990
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date January 2009