Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000145
Status:
COMPLETED
Last Update Posted:
2009-01-23
First Post:
1999-09-23
Brief Title:
Age-Related Eye Disease Study AREDS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
Age-Related Eye Disease Study AREDS
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None