Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345176
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2006-06-14
Brief Title:
Age-Related Eye Disease Study 2 AREDS2
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
Age-Related Eye Disease Study 2 AREDS2 A Multi-center Randomized Trial of Lutein Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids Docosahexaenoic Acid DHA and Eicosapentaenoic Acid EPA in Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2015-04
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:
AREDS2
Brief Summary:
Oral supplementation with the Age-Related Eye Disease Study AREDS formulation antioxidant vitamins C and E beta carotene and zinc has been shown to reduce the risk of progression to advanced age-related macular degeneration AMD Observational data suggest that increased dietary intake of lutein zeaxanthin carotenoids omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid DHA eicosapentaenoic acid EPA or both might further reduce this risk AREDS2 was designed to test whether adding lutein zeaxanthin DHA EPA or lutein zeaxanthin and DHA EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation
Detailed Description:
AREDS2 was a randomized double-masked placebo-controlled 2x2 factorial trial evaluating the risks and benefits of adding lutein 10 mg zeaxanthin 2 mg DHA 350 mg EPA 650 mg or both to the AREDS formulation which consisted of vitamins C 500 mg vitamin E 400 international units beta carotene 15 mg zinc 80 mg as zinc oxide and copper 2 mg as cupric oxide for the treatment of progression to advanced AMD The study enrolled 4203 participants aged 50 to 85 years with sufficiently clear ocular media to allow accurate assessment of AMD from fundus photographs Subjects were enrolled on the basis of the AREDS Simplified Severity Scale for defining risk categories for development of advanced age-related macular degeneration All participants were offered additional treatment with the original AREDS formulation now considered standard of care and 3 variations of this formula These are 1 no beta-carotene 2 lower amount of zinc 25 mg and 3 no beta-carotene and lower amount of zinc 25 mg Eligible participants were followed for a minimum of five years
Multiple ancillary studies were conducted using the parent study AREDS2 data to explore
1 Effects of oral supplementation of omega-3 fatty acids luteinzeaxanthin zinc and beta-carotene on cognitive function
1 Outcome is measured with a battery of tests administered over the telephone at baseline and at years 2 and 4 of the study
2 Primary outcome is the change in the composite score for the results of the cognitive function testing from baseline over time
2 Effects of oral supplementation of omega-3 fatty acids luteinzeaxanthin on cardiovascular disease
a Primary measure of cardiovascular morbidity and mortality
3 Effects of oral supplementation of omega-3 fatty acids luteinzeaxanthin on the peripheral retina
a Primary outcome is the development of peripheral drusen geographic atrophy reticular pigmentary changes and pseudoreticular drusen
4 Association of genotype polymorphisms with age-related macular degeneration and cataract
a Whole genome sequencing will be completed Evaluation of association genetic associations with disease will be conducted using AREDS controls
5 Association of genotype polymorphisms with progression of age-related macular degeneration
a Whole genome sequencing is conducted Progression from early to late and severe stages of AMD will be examined with the genotype data to evaluate the risks of progression associated with the genotype polymorphisms
6 Association of genotype polymorphisms with dietary intake a Whole genome sequencing is conducted Progression from early to late and severe stages of AMD will be examined regarding potential interaction of the dietary intake with the genotype data to evaluate the risks of progression
7 Association of genotype polymorphisms with AREDS2 supplements a Interaction of genetic polymorphisms with AREDS2 supplements for progression to late AMD will be evaluated using the data from the whole genome sequencing project
Multiple ancillary studies were conducted using the parent study AREDS2 data to explore
1 Effects of oral supplementation of omega-3 fatty acids luteinzeaxanthin zinc and beta-carotene on cognitive function
1 Outcome is measured with a battery of tests administered over the telephone at baseline and at years 2 and 4 of the study
2 Primary outcome is the change in the composite score for the results of the cognitive function testing from baseline over time
2 Effects of oral supplementation of omega-3 fatty acids luteinzeaxanthin on cardiovascular disease
a Primary measure of cardiovascular morbidity and mortality
3 Effects of oral supplementation of omega-3 fatty acids luteinzeaxanthin on the peripheral retina
a Primary outcome is the development of peripheral drusen geographic atrophy reticular pigmentary changes and pseudoreticular drusen
4 Association of genotype polymorphisms with age-related macular degeneration and cataract
a Whole genome sequencing will be completed Evaluation of association genetic associations with disease will be conducted using AREDS controls
5 Association of genotype polymorphisms with progression of age-related macular degeneration
a Whole genome sequencing is conducted Progression from early to late and severe stages of AMD will be examined with the genotype data to evaluate the risks of progression associated with the genotype polymorphisms
6 Association of genotype polymorphisms with dietary intake a Whole genome sequencing is conducted Progression from early to late and severe stages of AMD will be examined regarding potential interaction of the dietary intake with the genotype data to evaluate the risks of progression
7 Association of genotype polymorphisms with AREDS2 supplements a Interaction of genetic polymorphisms with AREDS2 supplements for progression to late AMD will be evaluated using the data from the whole genome sequencing project
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-EI-0025 | OTHER | National Eye Institute | None |
| N01-EY-5-0007 | OTHER_GRANT | None | None |
| HHS-N-260-2005-00007-C | OTHER_GRANT | None | None |
| CC-070025 | OTHER | None | None |