University of Iowa Hospitals and Clinics has been chosen to be a clinical center for the second stage of an age-related macular degeneration study called AREDS 2.
AREDS 1 proved that supplementation with vitamins C and E, beta carotene and zinc slowed the process of the disease. James Folk, MD, UI Department of Ophthalmology and Visual Sciences ophthalmologist and the principal investigator for the study at the hospital talks about the study:
What is age-related macular degeneration, and how common is the disease?
The disease is very common; it's the most common cause of blindness in this country and it involves a disease of the central part of the retina, which is called the macula. Patients who have dry macular degeneration simply have a wearing out of the cells and slow vision loss, but then some of them can also develop the wet form of macular degeneration which involves the ingrowth of abnormal blood vessels under the retina, and these blood vessels leak and hemorrhage and cause scarring with vision loss.
What is a drusen?
A drusen was first named by a German ophthalmologist who looked into someone who had macular degeneration and noticed yellow spots or deposits underneath the retina, and drusen actually is a name that means pebbles and they look like little stones, and they're the first sign of macular degeneration.
What is the purpose of this second study?
The second study is based on a couple of epidemiological studies which showed that people who ate fish had a reduced risk of macular degeneration and it's thought that that's due to the omega 3 polyunsaturated fatty acids, that's the good fat that reduce inflammation and reduce hardening of the arteries. And then there's also a pigment called lutein, a yellow pigment in the macula, and that blocks the harmful rays of light and is also decreased in people who have macular degeneration; so the thought is maybe if you supplement with lutein and increase that pigment, that may lower the progression of the disease.
Who is eligible to participate in the second stage of this age-related eye disease study?
We want people who do have the drusen, who have the early stage of macular degeneration. They can already have fairly severe dry disease, or even new blood vessels, but only in one eye. If they have it in both eyes, then they're probably a little bit too far advanced for us to see an effect, so we want them just in one eye, but this comprises, really, the majority of people who have this disease.
Earlier you talked about some dietary or other types of supplements that people can make changes with part of their daily living and sitting down at the dinner table. What will participants be asked to do as part of the study?
It's a fairly easy study for participants because they're allowed to take the vitamins and the zinc that was proved to be effective in the AREDS, the first study, but then they would be randomized to either taking the fish oil, the omega 3 oil, and the lutein, one or the other or both, or they might be randomized not to get either of those. We don't know if these substances are helpful and there are studies that show that sometimes vitamins can actually be harmful, and that's why we want to do this, to see if it helps, first of all, and to make sure it doesn't hurt. They will take these supplements for a total of five years and we'll just see them every year to basically check their vision and take a photograph of their eye.
You just kind of answered my next question here, how long will the study last. When you're talking about whether it's going to help versus maybe not having any effect or hopefully not do any harm, what are you hoping for with regard to how it would help patients with age-related macular degeneration?
Well, what we're hoping is that it will reduce the progression of this disease. The drusen in and of themselves cause minimal visual loss, it's just when you develop this atrophy, that's the dry form, where the cells become absent, or the wet form is when you develop the vision loss. So we're hoping that patients or people who take this omega 3 oil or lutein have a slower rate of progression. And we'll be taking very careful measurements of the visual acuity and we'll be analyzing the photographs and then we'll be comparing one group against the other to see if one does better than the other.
If someone would like to learn more about this study, or AMD in general, who should they call or contact?
I think it would be easiest just to call my office at 319-356-8161. |
