The primary objective of AREDS2 is to evaluate the effect of dietary xanthophylls (lutein/zeaxanthin) and/or omega-3 LCPUFAs (DHA and EPA) on progression to advanced AMD. This objective will be accomplished by collecting and assessing the data on approximately 4,000 AREDS2 participants aged 50 to 85 years (of which 65 participants are from the NIH center), who at the time of enrollment, have sufficiently clear lenses for quality fundus photographs and have either: 1) bilateral large drusen or 2) large drusen in one eye and advanced AMD (neovascular AMD or central geographic atrophy) in the fellow eye. The objectives of AREDS2 are to: 1. Study the effects of high supplemental doses of the dietary xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs (DHA and EPA) on the development of advanced AMD. 2. Study the effects of these supplements on moderate vision loss (doubling of the visual angle or the loss of 15 or more letters on the ETDRS chart). 3. Study the effects of these supplements on cataract. 4. Study the effects of eliminating beta-carotene in the original AREDS formulation on the development and progression of AMD. 5. Study the effects of reducing zinc in the original AREDS formulation on the development and progression of AMD. 6. Validate the fundus photographic AMD scale developed from the Age-Related Eye Disease Study.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIAEY000485-07
Application #
9155588
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
7
Fiscal Year
2015
Total Cost
Indirect Cost
Name
U.S. National Eye Institute
Department
Type
DUNS #
City
State
Country
Zip Code
Veerappan, Malini; El-Hage-Sleiman, Abdul-Karim M; Tai, Vincent et al. (2016) Optical Coherence Tomography Reflective Drusen Substructures Predict Progression to Geographic Atrophy in Age-related Macular Degeneration. Ophthalmology 123:2554-2570
Chew, Emily Y; Klein, Michael L; Clemons, Traci E et al. (2015) Genetic testing in persons with age-related macular degeneration and the use of the AREDS supplements: to test or not to test? Ophthalmology 122:212-5
Yiu, Glenn; Chiu, Stephanie J; Petrou, Philip A et al. (2015) Relationship of central choroidal thickness with age-related macular degeneration status. Am J Ophthalmol 159:617-26
Indaram, Maanasa; Agrón, Elvira; Clemons, Traci E et al. (2015) Changes in lens opacities on the age-related eye disease study grading scale predict progression to cataract surgery and vision loss: age-related eye disease study report no. 34. Ophthalmology 122:888-96
Chew, Emily Y; Clemons, Traci E; Peto, Tunde et al. (2015) Ciliary neurotrophic factor for macular telangiectasia type 2: results from a phase 1 safety trial. Am J Ophthalmol 159:659-666.e1
Nicholson, Benjamin P; Nigam, Divya; Toy, Brian et al. (2015) Effect of ranibizumab on high-speed indocyanine green angiography and minimum intensity projection optical coherence tomography findings in neovascular age-related macular degeneration. Retina 35:58-68
Petrou, Philip A; Cunningham, Denise; Shimel, Katherine et al. (2015) Intravitreal sirolimus for the treatment of geographic atrophy: results of a phase I/II clinical trial. Invest Ophthalmol Vis Sci 56:330-8
Chew, Emily Y; Klein, Michael L; Clemons, Traci E et al. (2015) Author reply: To PMID 24974817. Ophthalmology 122:e46-7
Chew, Emily Y; Clemons, Traci E; Agrón, Elvira et al. (2015) Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or Other Nutrient Supplementation on Cognitive Function: The AREDS2 Randomized Clinical Trial. JAMA 314:791-801
Chew, Emily Y (2015) There is level 1 evidence for intensive glycemic control for reducing the progression of diabetic retinopathy in persons with type 2 diabetes. Endocrine 49:1-3

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