Ingalls Memorial Hospital Participating In Groundbreaking Age Related Eye Disease Study

(November, 2006) The Irwin Retina Center at Ingalls Memorial Hospital in Harvey has been chosen to participate in the Age Related Eye Disease Study 2 (AREDS 2), sponsored by the National Eye Institute – National Institutes of Health.

The goal of the randomized study is to determine whether the nutritional supplements lutein, zeaxanthin and two nutrients found in fish oil – docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) – will slow the development of advanced age-related macular degeneration (AMD), the leading cause of vision loss in adults 60 years and older.

AREDS 2, which launched nationwide in October, follows on the heels of the original AREDS study that began in 1990 and ended in 2005. In that study, Ingalls was one of only 11 hospitals nationwide invited to participate and enrolled nearly 400 individuals of the 4,800 total who participated across the country.

The National Eye Institute estimates that as many as 4,000 individuals will participate in AREDS 2.

“The original AREDS found that taking a specific high dosage of certain antioxidants and zinc significantly reduced the risk of progression to advanced AMD and its associated visual loss,” explains David Orth, M.D., principal investigator of the study, board-certified ophthalmologist and retina-vitreous specialist on staff at Ingalls.

Dr. Orth has been principal investigator for more than 18 clinical trials and co-investigator for many others sponsored by the National Institutes of Health – National Eye Institute. In fact, he was one of the original principal investigators involved in the earliest clinical trials to find an effective treatment for patients with age-related macular degeneration. Dr. Orth serves as medical director of the Irwin Retina Center at Ingalls and is also a professor of ophthalmology at Rush University Medical Center.

Why AREDS 2?

Lutein and zeaxanthin are carotenoids – yellow and orange pigments found in many fruits and vegetables like corn, sweet potatoes, carrots, squash, tomatoes and especially in dark leafy greens such as kale, spinach and collards. Both are present in high levels in the retina and lens of the eye.

“Early research has shown that people who eat more foods with these nutritional ingredients may be at a lower risk of developing advanced AMD,” Dr. Orth added. “Studies like AREDS 2 are essential in helping test the possible benefits of these supplements for people with AMD.”

The study will also look at whether reducing or eliminating certain vitamins and minerals used in the first AREDS study will work as well as the original nutritional supplement did.

AREDS 2 participants will be divided into four groups. The first group will receive lutein/zeaxanthin and a placebo that resembles the DHA/EHA pill. A second group will receive DHA/EPA and a placebo that resembles the lutein/zeaxanthin pill; a third will receive both lutein/zeaxanthin and DHA/EPA; and the fourth will receive placebos resembling lutein/zeaxanthin and DHA/EPA.

“By comparing the first three groups with the placebo-only group, researchers will be able to see if there are benefits or risks to the treatment,” Dr. Orth said. “That is, do the eyes of people taking the study pills look better or worse than the eyes of individuals taking the placebos.”

AREDS 2 will enroll up to 4,000 individuals, and Ingalls has been designated as one of 13 high-yield centers within the United States. High-yield centers will recruit a minimum of 150 participants.

To qualify for participation in AREDS 2, individuals must meet the following criteria:
· Have large drusen in both eyes or large drusen in one eye and advanced AMD in the other eye;
· Be willing to have their eyes photographed once a year for the next five years;
· Be willing to take at least three nutritional supplement pills daily for at least five years.

Park Forest Man Says Original AREDS Helped Him

Leonard Davis, 79 of Park Forest, participated in the original AREDS study at Ingalls and hopes to be part of AREDS 2.

Davis was diagnosed with “wet” AMD in his right eye in 1983, with early “dry” AMD in his left eye.

In 1990, Davis enrolled in the AREDS study at Ingalls to slow down the possible progression of the disease in his left eye. Besides taking daily nutritional supplements, Davis visited the specialists at the Irwin Retina Center twice a year for eye examinations.

“I know that the study helped me, because the vision in my left eye stayed the same for 15 years,” he said. “I still read, I drive, day or night. I’m retired now, and I lead an active life. I enjoy my family. I work on the computer and email my friends and family. Macular degeneration hasn’t changed my life.”

Davis said he’s glad that he enrolled in the first study and hopes to participate in AREDS 2.

“Participating in a clinical trial is great,” he added. “It will help someone else even if it doesn’t help me.”

For more information about the AREDS 2 study available at Ingalls or to see if you qualify for participation, call Celeste Figliulo, research clinic coordinator at the Irwin Retina Center, at 708-915-6927.

What is AMD?

As the leading cause of vision loss in Americans 60 years of age and older, age-related macular degeneration is a disease that blurs the sharp, central vision you need for “straight-ahead” activities such as reading, sewing and driving. AMD affects the macula, the part of the eye that allows you to see fine detail.

The macula itself is located in the center of the retina, the light-sensitive tissue at the back of the eye. The etina instantly converts light, or an image, into electrical impulses and then sends these impulses, or nerve signals, to the brain.

In some cases, AMD advances so slowly that people notice little change in their vision. In others, the disease progresses faster and may lead to a loss of vision in both eyes.

The most common types of AMD changes are tiny yellowish spots beneath the retina called drusen, which can be seen by ophthalmologists and on photographs of the eye. Most people over the age of 60 have a few small drusen. Many large drusen may indicate AMD is present, but vision may still be nearly normal.

About 85 to 90 percent of people with AMD have the “dry” type in which the outer layers of the retina lowly break down. This process may lead to a gradual blurring of vision that individuals may notice when they try to read. There are three types of dry AMD: early AMD, which involves a few drusen and no symptoms or vision loss; intermediate AMD, which consists of drusen and blurred central vision; and advanced dry AMD, which in addition to drusen, involves a breakdown of light-sensitive cells and supporting tissue in the central retina area, leading to more severe difficulty reading or recognizing faces.

Once dry AMD has reached the advanced stage, no treatment is available to prevent vision loss. However, early treatment can delay or even prevent progression to the advanced stage.

“Wet” AMD involves more rapid and severe vision loss. Straight lines appear crooked and distorted, an effect caused by abnormal blood vessels growing under the retina and leaking fluid and blood that, in essence, lift up the retina. While not curable, wet AMD can be treated with laser surgery, photodynamic therapy and injections of drugs into the eye.

AMD does not, by itself, result in total blindness. Most people with severe AMD can be assisted by low-vision aids for reading, move about independently and continue activities that do not require detailed vision.

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