Ingalls, Illinois Retina to Participate in Landmark Study Comparing Treatments for ‘Wet’ Macular Degeneration
(April, 2008) The Irwin Retina Center at Ingalls Memorial Hospital in Harvey, together with Illinois Retina Associates, has been chosen by the National Eye Institute to participate in a landmark clinical research study to compare two drugs for the treatment of “wet” age-related macular degeneration (AMD).
Ingalls/Illinois Retina is one of two sites in Illinois (and one of only 47 sites across the nation) chosen to participate in the two-year, 1,200-patient study.
The Comparison of Age-Related Macular Degeneration Treatment Trials (CATT) study will evaluate Lucentis (ranibizumab) and Avastin (bevacizumab) for the treatment of wet AMD. Both drugs, which are injected directly into the eye, stop the growth of abnormal blood vessels and leakage.
“Lucentis was approved by the U.S. Food and Drug Administration (FDA) in June of 2006 for the treatment of advanced, or wet, AMD,” explains David Orth, M.D., principal investigator for CATT and medical director of the Irwin Retina Center at Ingalls.
The approval was based on previous clinical trials that showed Lucentis slows vision loss from wet AMD. In addition, nearly one-third of patients showed some improvement in vision at 12 months, as measured on an eye chart.
Approved by the FDA in 2004 as a treatment for advanced colorectal cancer, Avastin is a drug closely related to Lucentis and has been widely used off-label to treat wet AMD. Avastin is thought to remain in the eye longer than Lucentis, possibly allowing for less frequent injections.
Both therapies are manufactured by Genentech, Inc., and work by interfering with proteins needed for growth of new blood vessels. However, the cost of the two drugs varies widely. Lucentis costs roughly $2,000 per dose for wet AMD treatment, while Avastin runs less than $100.
In addition to determining whether Avastin is as good as Lucentis or better, the CATT study also hopes to establish how much therapy a patient requires.
“This is a landmark study,” Dr. Orth added. “We want to know whether Avastin is more effective, less effective or the same as Lucentis for treating wet age-related macular degeneration. Also, we want to know whether treating less frequently than every month can provide the same benefits as treating on a monthly basis.”
According to Genentech-sponsored studies, the recommended treatment is one dose a month for 12 months, but physicians using the two different medications believe patients may benefit just as much from far less therapy.
“Patients being treated for wet AMD don’t see very well,” Dr. Orth explained. “So they rely on someone to bring them in for treatment. If we can treat them less often with an equally effective therapy, that’s a real benefit – both in terms of cost and convenience.”
Background on Wet AMD
AMD is a disease that damages the macula. The macula is the area of the retina responsible for central vision. AMD is a leading cause of blindness among older Americans. Nearly two million Americans are visually impaired by AMD, while more than seven million are at increased risk of vision loss from the disease.
Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula. These new blood vessels leak blood and fluid, damaging the macula and causing a rapid loss of vision. The growth of new blood vessels is called angiogenesis or neovascularization.
Research from the National Institutes of Health has helped establish that a protein called vascular endothelial growth factor (VEGF) is an important element in angiogenesis. This research provided a stimulus for the development of a number of anti-angiogenic or anti-VEGF drugs, including Lucentis and Avastin.
Visual impairment from AMD can lead to loss of independence and a reduced quality of life. The CATT study will evaluate whether the treatment burden for patients can be reduced without compromising effectiveness.
For more information regarding the Comparison of Age Related Macular Degeneration Treatment Trials, contact Linda Arredondo, RN at the Irwin Retina Center at Ingalls Memorial Hospital 708.915.6943.
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