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Scientists found that people at high risk of developing advanced stages of AMD, a leading cause of vision loss, lowered their risk by about 25 percent when treated with a high-dose combination of vitamin C, vitamin E, beta-carotene, and zinc. In the same high risk group -- which includes people with intermediate AMD, or advanced AMD in one eye but not the other eye -- the nutrients reduced the risk of vision loss caused by advanced AMD by about 19 percent. For those study participants who had either no AMD or early AMD, the nutrients did not provide an apparent benefit. The clinical trial -- called the Age-Related Eye Disease Study (AREDS) -- was sponsored by the National Eye Institute (NEI), one of the Federal government's National Institutes of Health.

"This is an exciting discovery because, for people at high risk for developing advanced AMD, these nutrients are the first effective treatment to slow the progression of the disease," said Paul A. Sieving, M.D., Ph.D., director of the NEI. "AMD is a leading cause of visual impairment and blindness in Americans 65 years of age and older. Currently, treatment for advanced AMD is quite limited. These nutrients will delay the progression to advanced AMD in people who are at high risk -- those with intermediate AMD in one or both eyes, or those with advanced AMD in one eye already.

"The nutrients are not a cure for AMD, nor will they restore vision already lost from the disease," Dr. Sieving said. "But they will play a key role in helping people at high risk for developing advanced AMD keep their vision."

A common feature of AMD is the presence of drusen, which are yellow deposits under the retina. Often found in people over age 60, drusen can be seen by an eye care professional during an eye exam in which the pupils are dilated. Drusen by themselves do not usually cause vision loss, but an increase in their size and/or number increases a person's risk of developing advanced AMD, which can cause serious vision loss.

The three stages of AMD analyzed in this study are:

1. Early AMD. People with early AMD have, in one or 
   both eyes, either several small drusen or a few 
   medium-sized drusen; these people do not have 
   vision loss from AMD.
   
2. Intermediate AMD. People with intermediate AMD 
   have, in one or both eyes, either many medium-sized 
   drusen or one or more large drusen; in these people, 
   there is usually little or no vision loss.
   
3. Advanced AMD. In addition to drusen, people 
   with advanced AMD have, in one or both eyes, either:

• A breakdown of light-sensitive cells and supporting 
  tissue in the central retinal area (advanced dry form); or
• Abnormal and fragile blood vessels under the 
  retina that can leak fluid or bleed (wet form).

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These two forms of advanced AMD can cause serious vision loss. Scientists are unsure about how or why an increase in the size and/or number of drusen can sometimes lead to advanced AMD, which affects the sharp, central vision required for the 'straight ahead' activities in our daily routine, such as reading, driving, and recognizing faces of friends. One observation is that the larger and more numerous the drusen, the higher the risk of developing either form of advanced AMD. People who have advanced AMD in one eye are at especially high risk of developing advanced AMD in the other eye. The formulation used in the study contained several antioxidant vitamins, which are nutrients that can help maintain healthy cells and tissues. They also contained zinc, which is an important mineral incorporated into many body tissues.

The nutrients evaluated by the AREDS researchers 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 (Copper was added to the AREDS formulations containing zinc to prevent copper deficiency, which may be associated with high levels of zinc supplementation). In this trial, the NEI collaborated with Bausch & Lomb, an eye care company that provided the formulation evaluated by the AREDS researchers and financially supported the laboratory testing and distribution of study medications.

"Previous studies have suggested that people who have diets rich in green, leafy vegetables have a lower risk of developing AMD," said Frederick Ferris, MD, director of clinical research at the NEI and chairman of the AREDS. "However, the high levels of nutrients that were evaluated in the AREDS are very difficult to achieve from diet alone.

"Almost two-thirds of AREDS participants chose to take a daily multivitamin in addition to their assigned study treatment," Dr. Ferris said. "The AREDS also showed that, even with a daily multivitamin, people at high risk for developing advanced AMD can lower the risk of vision loss by adding a formulation with the same high levels of antioxidants and zinc used in the study."

The Age-Related Eye Disease Study involved 4,757 participants, 55-80 years of age, in 11 clinical centers nationwide. Participants in the study were given one of four treatments: 1) zinc alone; 2) antioxidants alone; 3) a combination of antioxidants and zinc; or 4) a placebo, a harmless substance that has no medical effect. The benefits of the nutrients were seen only in people who began the study at high risk for developing advanced AMD -- those with intermediate AMD, and those with advanced AMD in one eye only. In this group, those taking "antioxidants plus zinc" had the lowest risk of developing advanced stages of AMD and its accompanying visual loss. Those in the "zinc alone" or "antioxidant alone" groups also reduced their risk of developing advanced AMD, but at more moderate rates compared to the "antioxidants plus zinc" group. Those in the placebo group had the highest risk of developing advanced AMD.

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