Year Approved by the FDA: Not applicable*
Effective for: Intermediate dry age-related macular degeneration
How it works: There is currently no specific treatment or cure for dry macular degeneration. However, the National Eye Institute’s Age-Related Eye Disease Study (AREDS) found that taking a specific high dose formula of vitamins and mineral supplements called the AREDS formulation significantly reduces the risk of progression of intermediate-stage macular degeneration to advanced or wet macular degeneration. Note: The stage of macular degeneration can be determined only through a comprehensive eye exam performed by a licensed eye care specialist.
Progression of macular degeneration to advanced stages is associated with a build-up of substances that may be toxic to the retina and cause damage. The AREDS formulation is comprised of vitamins and minerals which act as antioxidants (substances which block or prevent damage due to toxic compounds) and zinc. The formulation found to be effective in the AREDS study contained 500 milligrams of vitamin C, 400 International Units of vitamin E, 15 milligrams of beta-carotene, 80 milligrams of zinc as zinc oxide, and two milligrams of copper as cupric oxide.
Though many of the antioxidant supplements provided in the AREDS formulation can be obtained in other over-the-counter vitamin and mineral supplements, the dosages required to achieve maximum efficacy are far greater than those that are available in other supplements. You can ask your pharmacist to help you find formulations that have “AREDS” on the label.
Supplements included in the AREDS formulation may contradict with other medical conditions and/or medications that you are taking, thus patients are strongly encouraged to talk with their physician before taking any form of vitamin/mineral supplement. There is no evidence that the AREDS formula provided any benefit to people with early-stage age-related macular degeneration. Patients with intermediate age-related macular degeneration in one or both eyes or advanced age-related macular degeneration (dry or wet) in one eye but not the other eye might consider taking the formula.
Most common side effects: Some participants in the clinical trials reported minor side effects from the treatments. A small percent of participants assigned to the zinc treatments developed urinary tract problems that required hospitalization. Yellowing of the skin, a well-known side effect of large doses of beta-carotene, was reported slightly more often by participants taking antioxidants.
There is some evidence that beta-carotene supplements increase the risk of lung cancer in current smokers, and possibly in former smokers (even after several years without smoking). In deciding whether to include beta-carotene in a formulation designed to slow the development of advanced age-related macular degeneration, you and your doctor should balance the apparent increase in the risk of lung cancer associated with beta-carotene with the risk of age-related macular degeneration progression.
*As of December 2006, the Food and Drug Administration (FDA) regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval.
A thoughtful evaluation must be performed by a physician before taking any medications, over-the-counter drugs, supplements, or herbs. The American Health Assistance Foundation does not endorse any of these medications, vitamins, or herbs. A qualified physician should make an informed decision based on each person's medical history and current prescriptions. The medication summaries provided do not include all of the information important for patient use and should not be used as a substitute for professional medical advice. The prescribing physician should be consulted concerning any questions that you have.
The information provided in this section of our website was obtained from the National Institutes of Health (NIH)/National Eye institute (NEI), the Food and Drug Administration (FDA), the National Library of Medicine, and research scientists specializing in macular degeneration.
Reviewed on 2/14/2008