Protocol Number: 07-EI-0025

Title:

The 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

Number:

07-EI-0025

Summary:

Among the estimated 937,000 blind people in the United States, approximately 90% are age 60 and older. One of the leading causes of vision loss in this age group is age-related macular degeneration. This study will evaluate whether certain vitamins and fatty acids can help prevent or slow down the progress of age-related macular degeneration. Researchers also want to learn if nutrients have effects on the development of cataracts.

Patients ages 50 to 85 who are at high risk of having advanced age-related macular degeneration may be eligible for this study. About 4,000 people will participate for 5 years. At the first clinic visit, patients will have an eye examination, have their eyes photographed, and learn about the study. They will receive a supply of placebos (sugar pills) and the standard formulation of the Age-Related Eye Disease Study supplement, which has vitamin C, vitamin E, beta-carotene, zinc oxide, and cupric oxide (copper). Patients who have smoked within the past year will not receive the standard formulation, for there is an increased risk of lung cancer for people taking beta-carotene. The second visit, 1 to 3 months later, involves an eye examination, vision check, and blood sample taken if patients agree to enter a substudy of other nutrient formulations.

This study uses omega-3 long-chain polyunsaturated fatty acids (fish oils): docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Patients are placed randomly into four groups: receiving a placebo; lutein and zeaxanthin only; fatty acids only; and lutein and zeaxanthin plus fatty acids. During study visits and phone calls, patients will be asked about possible side effects. After 1 year, they will have an eye examination and photographs of the eyes, and will be asked about side effects from the pills they have been taking. There will be annual follow-ups for the study's 5 year duration.

Risks include those involved in any routine eye examination such as discomfort or allergic reaction to eye drops used during eye examinations and drops for dilating the eyes that can cause a sudden increase in pressure in very few individuals. The supplements taken can also involve some symptoms. Fatty acids can cause mild gastrointestinal problems. Vitamin E side effects are rare but include fatigue and muscle weakness. In people without enough vitamin K, high doses of vitamin E may slow down clotting of blood. High doses of zinc can sometimes causes stomach upset.

This study may have direct benefits for participants. They can learn more about their own eyes and eye disease. Knowledge gained can also help other people at risk for developing eye diseases in the future.

Sponsoring Institute:

National Eye Institute (NEI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Age Related Macular Degeneration

Age-Related Cataract

Lutein/zeaxanthin

Omega-3 Fatty Acids

DHA/EPA

Recruitment Keyword(s):

Age-Related Macular Degeneration

AMD

Age-Related Cataracts

Age-Related Eye Disease

Condition(s):

Age-Related Macular Degeneration (AMD)

Cataracts

Investigational Drug(s):

Lutein, Zeaxanthin, DHA, EPA, Vit C, Vit E, Beta-carotene, zinc oxide, cupric ox

Investigational Device(s):

None

Interventions:

Drug: Lutein, zeaxanthin, DHA, EPA

Drug: Vitamins C, E, beta-carotene

Drug: Zinc oxide, Copper oxide

Drug: Lutein, Zeaxanthin, DHA, EPA, Vit C, Vit E, Beta-carotene, zinc oxide, cupric ox

Supporting Site:

National Eye Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Smiddy WE, Fine SL. Prognosis of patients with bilateral macular drusen. Ophthalmology. 1984 Mar;91(3):271-7.

Kini MM, Leibowitz HM, Colton T, Nickerson RJ, Ganley J, Dawber TR. Prevalence of senile cataract, diabetic retinopathy, senile macular degeneration, and open-angle glaucoma in the Framingham eye study. Am J Ophthalmol. 1978 Jan;85(1):28-34.

Gragoudas ES, Adamis AP, Cunningham ET Jr, Feinsod M, Guyer DR; VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004 Dec 30;351(27):2805-16.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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