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AREDS2 will examine effects of lutein, zeaxanthin
Five years after one NIH study concluded that antioxidants help high-risk patients, a second study seeks to add and refine information.
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The National Eye Institute at the National Institutes of Health began enrolling patients for a follow-up to build upon information gathered in an earlier study of dietary supplements for prevention of age-related macular degeneration.
The Age-Related Eye Disease Study 2 (AREDS2) will look specifically at lutein and zeaxanthin, plant-derived yellow pigments that accumulate in the macula, and the omega-3 fatty acids DHA and EPA, derived from fish and vegetable oils, added to the study formulation established by the original AREDS.
Emily Y. Chew, MD, study chair and deputy director of the Division of Epidemiology and Clinical Research at the NEI talked to Ocular Surgery News about the ongoing study.
“Our primary goal is to see whether we can prevent advanced age-related macular degeneration from developing,” she said. “We were able to reduce the development of advanced AMD with the AREDS formulation by about 25%, so we’re now looking at other factors that might be important.”
Study goals
The main goal of the study is to establish whether lutein, zeaxanthin and certain omega-3 fatty acids will decrease a person’s risk of progression to advanced AMD, which often leads to vision loss.
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Image: Used with permission from the National Eye Institute, National Institutes of Health. |
“The results of the AREDS study as well as other studies suggest that people who eat higher amounts of green leafy vegetables that contain lutein and people who eat two or more servings a week of fish have a lower risk of having macular degeneration than those that don’t eat it at all,” Dr. Chew said. “Of course, these are observational data, and who knows what’s different about these people, so we have to do a randomized trial to test these treatments, and that’s what we’re doing with AREDS2.”
A goal, Dr. Chew explained, is to refine the current recommended combination of vitamins and minerals that was created with the original AREDS.
Specifically, she said, researchers were looking to reduce the amount of zinc due to advice from nutritional experts and eliminate beta-carotene since it puts smokers at a higher risk of developing lung cancer.
“One small trial suggests that this large dose of 80 mg (of zinc) is important, but our nutritional experts have all said that your body doesn’t absorb that much,” Dr. Chew said. “It basically only absorbs a certain amount so we’re going to lower the zinc and see whether there’s any difference.”
If the nutrients at the focus of AREDS2 are beneficial, she hoped they could eliminate beta-carotene from the recommended dosage of AREDS1 and offer the preventive treatment to smokers.
“In the AREDS study, we found a combination of vitamins and minerals that effectively slowed the progression of AMD for some people,” Paul A. Sieving, MD, PhD, director of the NEI, said in a press release. “Now, we will conduct this more precisely-targeted study to see if the new combination of nutrients can reduce AMD progression even further.”
Enrolling patients
Researchers will enroll 4,000 people between 50 and 85 years of age with AMD in both eyes, or advanced AMD in one eye. They must be available for yearly eye examinations for at least 5 years.
Dr. Chew said they began enrollment last month and need many more patients to work with their 88 clinics. She said she had already noticed a difference between this population and the population from AREDS.
“These patients are a little bit older than AREDS patients,” she told OSN. “These are all patients who have some form of macular degeneration, either a moderate risk with bilateral large drusen or patients with advanced AMD in one eye already.”
Physicians still have plenty of time to refer patients, Dr. Chew insisted, and she expressed gratitude for the cooperation between the many community clinics and the academic world.
“Until we get the results from AREDS2, we encourage people with AMD to visit their eye care professional to see if they need to take the AREDS vitamin and mineral formulation,” she said in a press release. “This alone could save more than 300,000 people from vision loss over the next 5 years.”
For more information:
- Emily Y. Chew, MD, can be reached at the National Eye Institute, 31 Center Dr., Bethesda, MD 20892-2510; 301-496-6583; fax: 301-496-2297; e-mail: echew@nei.nih.gov.
Reference:
- AREDS2 Web site: www.areds2.org
- Katrina Altersitz is an OSN Staff Writer who covers all aspects of ophthalmology.