Age-Related Eye Disease Study 2 (AREDS2)
Lykilorð
Útdráttur
Lýsing
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 4,203 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, lutein/zeaxanthin, 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, lutein/zeaxanthin on cardiovascular disease
a. Primary measure of cardiovascular morbidity and mortality
3. Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin 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.
Dagsetningar
| Síðast staðfest: | 03/31/2015 |
| Fyrst lagt fram: | 06/13/2006 |
| Áætluð skráning lögð fram: | 06/22/2006 |
| Fyrst sent: | 06/26/2006 |
| Síðasta uppfærsla lögð fram: | 04/12/2015 |
| Síðasta uppfærsla sett upp: | 05/04/2015 |
| Dagsetning fyrstu skilaðra niðurstaðna: | 10/31/2013 |
| Dagsetning fyrstu niðurstaðna QC: | 10/31/2013 |
| Dagsetning fyrstu birtu niðurstaðna: | 12/23/2013 |
| Raunverulegur upphafsdagur náms: | 08/31/2006 |
| Áætlaður aðallokunardagur: | 09/30/2012 |
| Áætlaður dagsetningu rannsóknar: | 09/30/2012 |
Ástand eða sjúkdómur
Íhlutun / meðferð
Dietary Supplement: Lutein/Zeaxanthin
Dietary Supplement: DHA/EPA
Drug: Lutein/Zeaxanthin + DHA/EPA
Stig
Armhópar
| Armur | Íhlutun / meðferð |
|---|---|
| Active Comparator: Lutein/Zeaxanthin lutein (10mg)/zeaxanthin (2 mg) | Dietary Supplement: Lutein/Zeaxanthin 10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules) |
| Active Comparator: DHA/EPA DHA (350 mg)/EPA (650 mg) | Dietary Supplement: DHA/EPA Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules) |
| Active Comparator: Lutein/Zeaxanthin + DHA/EPA lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg) | Drug: Lutein/Zeaxanthin + DHA/EPA 10 mg lutein and 2 mg zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules) |
| Placebo Comparator: Placebo/Control Considered control because all participants received the AREDS formulation |
Hæfniskröfur
| Aldur hæfur til náms | 50 Years Til 50 Years |
| Kyn sem eru hæf til náms | All |
| Tekur við heilbrigðum sjálfboðaliðum | Já |
| Viðmið | Inclusion Criteria: - Men and women between the ages of 50 and 85 years - Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye Exclusion Criteria: - Ocular media not clear enough to allow good fundus photography |
Útkoma
Aðal niðurstöður ráðstafanir
1. Development of Advanced AMD in People at Moderate to High Risk for Progression. [5 years of follow-up]
Aðgerðir vegna aukaatriða
1. Progression to Moderate Vision Loss [5 years of follow-up]
2. Adverse Events [5 years of follow-up]
3. Progression to Cataract Surgery [5 years of follow-up]
Aðrar útkomuaðgerðir
1. Incident Cardiovascular Disease [5 years of follow-up]
2. Cognition as Measured by a Telephone Battery [5 years of follow-up]
3. Prevalence of Peripheral Changes as Measured Using OPTOS Imaging [5 years of follow-up]
4. Genetics for the Association of AMD and Cataract [5 years of follow-up]
5. Genetics for the Progression of AMD and Cataract [5 years of follow-up]
