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 degernation (AMD). The two drugs, Lucentis (ranibizumab) and Avastin (bevacizumab). AMD is a disease that damages the macula. The macul 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.
Lucentis was approved by the US Food and Drug Administration (FDA) in June 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 FDA approved 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 AMD. Avastin is thought to remain in the eye longer than Lucentis, and therefore possibly allow for less frequent injections.
The Lucentis – Avastin trial will determine the relative safety and effectiveness of treating wet AMD in 1,200 patients. 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 comprpomising effectiveness, would reduce the treatment burden for patients, and produce a potential cost savings.