Cleveland Clinic Cole Eye Institute Chairman Led Landmark Comparative Effectiveness Trial
April 27, 2011
A new study published online today in The New England Journal of Medicine (NEJM) shows bevacizumab (Avastin) is as effective as ranibizumab (Lucentis), the current Food and Drug Administration-approved drug for treating age-related macular degeneration (AMD).
The results are from the landmark “Comparison of AMD Treatments Trials” (CATT) study, a pioneering comparative effectiveness trial made possible through funding by the National Eye Institute.
“For years, ophthalmologists have been using intravitreal bevacizumab to treat neovascular AMD without data regarding efficacy and safety from well-controlled studies,” said Daniel F. Martin, MD, study chair for CATT and chairman of the Cole Eye Institute at Cleveland Clinic. “Patients and clinicians can now feel confident that bevacizumab is therapeutically equivalent to ranibizumab.”
Derived from the same protein as bevacizumab – a well-known anti-cancer drug - ranibizumab was developed to block blood vessel growth in AMD patients. In 2005, two Genentech-sponsored clinical trials established ranibizumab as highly effective for the treatment of wet AMD. During the year between the announcement of the trial results and the release of ranibizumab, ophthalmologists began injecting AMD patients with low doses of bevacizumab due to its similarity to ranibizumab and its availability. One dose of ranibizumab costs approximately $2,000, while bevacizumab costs about $50 per dose. Both drugs are manufactured by Genentech.
Comparative effectiveness trials like (CATT) are necessary to the practice of evidence-based medicine, providing rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients.
Although funded with $1.1 billion through the 2009 American Recovery and Reinvestment Act, there remains insufficient infrastructure for the implementation of federally sponsored CER trials.
In the process of designing this trial, Dr. Martin and study co-chairs Maureen Maguire, PhD, and Stuart Fine, MD, blazed a trail in comparative effectiveness research.
Facing a number of significant roadblocks to billing, payment and design, the CATT leadership proposed language to an amendment to the Medicare Improvements for Patients and Providers Act of 2008 to eliminate barriers to alternative payment mechanisms for NIH-sponsored trials. Although passed on July 15, 2008, there is still no defined Center for Medicare & Medicaid Services (CMS) process for initiating discussion of such alternative payment mechanisms.
CATT found visual acuity improvement was virtually identical (within one letter difference on an eye chart) for either drug when given monthly. In addition, no difference was found in the percentage of patients who had an important gain or loss in visual function. When each drug was given on an “as needed” (PRN) schedule, there also was no difference (within one letter) between drugs. PRN dosing required four to five fewer injections per year than monthly treatment but still resulted in substantial gains in vision. Visual gains were about two letters less with PRN than with monthly treatment but overall visual results were still excellent.
"In addition to the primary finding of equivalence between ranibizumab and bevacizumab for visual acuity, CATT also demonstrates that PRN dosing is a viable treatment option for either of these drugs," said Martin. "Substantial visual acuity gains may be accomplished with a lower treatment burden.”
AMD is the leading cause of vision loss and blindness in older Americans. For many people, AMD severely impedes mobility and independence by limiting their ability to drive, read, recognize faces or perform tasks that require hand-eye coordination.
“Over 250,000 patients are treated each year for AMD and the majority receives bevacizumab. Given the lack of efficacy data regarding bevacizumab for AMD treatment, the NEI had an obligation to patients and clinicians to conduct this study,” said Paul A. Sieving, MD, PhD, director of the NEI.
This and other findings from the Comparison of AMD Treatments Trials (CATT) will appear in the May 19, 2011 printed edition of The New England Journal of Medicine. CATT is funded by the National Eye Institute (NEI), a part of the National Institutes of Health.
About Cole Eye Institute
Cleveland Clinic Cole Eye Institute, which opened in November 1999, integrates clinical care, research and education in one 130,000-square-foot building. It includes five operating rooms, a 77-seat auditorium, 68 clinical suites, an expanded ophthalmic library, and state-of-the-art research laboratories. The institute is ranked among the Top 10 hospitals for eye care in the country by U.S. News & World Report in its annual hospital survey, making it No. 1 in Ohio.
About Cleveland Clinic
Celebrating its 90th anniversary, Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. It was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. About 2,800 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. Cleveland Clinic Health System includes a main campus near downtown Cleveland, nine community hospitals and 15 Family Health Centers in Northeast Ohio, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and opening in 2013, Cleveland Clinic Abu Dhabi. In 2010, there were 4 million visits throughout the Cleveland Clinic health system and 155,000 hospital admissions. Patients came for treatment from every state and from more than 100 countries. Visit us at www.clevelandclinic.org. Follow us at www.twitter.com/ClevelandClinic.
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