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The National Eye Institute (NEI) of the National Institutes of Health (NIH) announces the start of a multicenter clinical trial to compare the relative safety and effectiveness of two drugs currently used to treat advanced age-related macular degeneration (AMD). The two drugs are Lucentis (ranibizumab) and Avastin (bevacizumab). 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.
“Visual impairment from AMD can lead to loss of independence and a reduced quality of life,” said Paul A. Sieving, M.D., Ph.D., director of NEI. “This clinical trial will evaluate whether the treatment burden for patients can be reduced without compromising effectiveness.”
Lucentis was approved by the U.S. Food and Drug Administration (FDA) in June of 2006 for the treatment of advanced, or wet, AMD. The approval was based on evidence from clinical trials showing that Lucentis slows the rate of progression of vision loss from wet AMD. In addition to a low rate of developing vision loss, approximately one-third of patients treated in these trials had some improvement in vision, as measured on an eye chart, at 12 months.
Avastin is a drug closely related to Lucentis. It was approved by the FDA in 2004 as an intravenous treatment for patients with advanced colorectal cancer and therefore has been available for what is called off-label use for other health conditions. It has been widely used off-label to treat wet AMD. Avastin is thought to remain in the eye longer than Lucentis and therefore possibly allow for less frequent injections.
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. NIH-supported research 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.
The Lucentis—Avastin trial will determine the relative safety and effectiveness of treating wet AMD in 1,200 patients who will be treated with either:
- Injection of Lucentis on a fixed schedule of once every four weeks for one year, with the patient being assigned randomly in the second year to either an injection of Lucentis every four weeks or on a variable schedule depending on the patient’s response to treatment;
- Injection of Avastin on a fixed schedule of once every four weeks for one year, with the patient being assigned randomly in the second year to either an injection of Avastin every four weeks or on a variable schedule depending on the patient’s response to treatment;
- Injection of Lucentis on a variable schedule;
- Injection of Avastin on a variable schedule.
The primary outcome measure will be change in visual acuity. Secondary outcome measures will include number of treatments, anatomical changes in the retina, adverse events, and cost.
This clinical trial will be conducted at 47 clinical centers across the country. It is hoped the results of this study will improve the treatment of wet AMD. Reducing the frequency of treatments without compromising effectiveness would reduce the treatment burden for patients and produce a potential cost savings.
For a list of clinical centers, eligibility recruitments, and other information, go to: http://www.nei.nih.gov/CATT.
Lucentis and Avastin are products of Genentech, Inc.
The National Eye Institute (NEI) is part of the National Institutes of Health (NIH) and is the Federal government’s lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness. For more information, visit the NEI Website at http://www.nei.nih.gov/.
The National Institutes of Health (NIH) - The Nation’s Medical Research Agency - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.