Nutrient-Based Treatment May Prevent or Slow Disease Progression

Nearly 2 million Americans have vision loss from age-related macular degeneration (AMD) and another 7 million with AMD are at substantial risk for vision loss. To address the need for effective treatment, UAB is one of nearly 100 clinical centers participating in the Age-Related Eye Disease Study 2 (AREDS 2), a nationwide National Institutes of Health-funded study.

“The new investigation builds on findings from the original AREDS study that high-dose oral antioxidant vitamins and minerals (vitamin E, vitamin C, beta carotene, and zinc) reduced risk of progression to advanced AMD,” says Director of the Clinical Research Unit in the Department of Ophthalmology Cynthia Owsley, PhD, MSPH, AREDS 2 principal investigator. Other members of the UAB team are John O. Mason, MD; Milton F. White, MD; Richard M. Fiest, MD; Michael A. Albert, Jr, MD; and Martin L. Thomley, MD.

AREDS 2 is a phase 3 randomized clinical trial that will refine the original study by adding high-dose lutein and zeaxanthin, omega-3 long-chain polyunsaturated fatty acids, or both, as a treatment for AMD, cataracts, and moderate vision loss.

“Our main goal is to determine whether the addition of the plant derivatives lutein and zeaxanthin to the study formulation decreases progression to advanced AMD, which often leads to blindness,” she says. Other study goals include providing information on the clinical course, prognosis, and risk factors for development and progression of AMD and cataracts, and evaluating the effect of eliminating beta carotene, reducing zinc, or both in the original AREDS formulation.

Macular degeneration is usually classified as wet or dry. Vision loss tends to be more rapid and severe in wet AMD, and patients report that straight lines appear crooked and distorted. This effect is caused by abnormal blood vessels growing beneath the retina and leaking fluid and blood, which lift the retina. Although wet AMD sometimes responds to laser surgery, photodynamic therapy, or intraocular injections of medications, none of these treatments is curative. Once dry AMD reaches an advanced stage, called geographic atrophy, no treatment can prevent progressive vision loss.

Currently, effective pharmacological and surgical treatment options for AMD are limited, costly, and may result in blinding complications. The likelihood of vision loss among patients with wet AMD can be reduced by antivascular endothelial growth factor A treatment, photodynamic therapy, and laser photocoagulation, however, no effective treatment options are available for the majority of patients with the disease.

“AREDS 2 will enroll 4000 participants nationwide aged 50 to 85 years with dry AMD in both eyes or advanced AMD in one eye,” says Katherine Kallies, project coordinator in charge of recruitment, screening, follow-up, and communication with the clinical trial coordinating center. “At UAB, we plan to enroll a minimum of 45 participants who will undergo yearly eye exams for at least 5 years,” Kallies says.

“The exams are noninvasive and much like a typical eye examination. We welcome all referrals. Further screening will determine if potential participants meet study inclusion criteria,” Owsley says.

For more information:
Dr. Cynthia Owsley
1.800.UAB.MIST
mist@uabmc.edu