SAN FRANCISCO, May 2, 2016 /PRNewswire-USNewswire/ -- New results from a landmark clinical trial have confirmed the long-term effectiveness and safety of the drugs Avastin and Lucentis for treating age-related macular degeneration, a major cause of blindness. The study found that half of eyes treated with either drug after five years maintained vision typically considered good enough to drive and read. The researchers called the results "remarkable" given that before these drugs were available the majority of people with the condition would have gone legally blind. The study is being published online today in Ophthalmology, the journal of the American Academy of Ophthalmology.
In 2008, the National Eye Institute funded a comparison trial of two drugs to treat a form of macular degeneration, called neovascular or "wet" AMD. It is responsible for 90 percent of all AMD-related blindness. The researchers compared two injectable anti-vascular endothelial growth factor drugs manufactured by Genentech. One was Lucentis (ranibizumab) which was approved in 2006 by the U.S. Food and Drug Administration for treating wet AMD. The other was Avastin (bevacizumab), a drug approved for colon cancer, but used off-label to treat AMD. Lucentis costs about $2,000 per dose, versus $50 a dose for Avastin. Before this study, no U.S. clinical trial data existed to verify the more affordable drug's safety and efficacy.
The researchers studied 1,200 patients with wet AMD using either drug. After five years, researchers followed up with 647 of the patients who were still living. They found that 50 percent of eyes had 20/40 vision or better. Researchers also found that treating patients as needed rather than on a monthly basis may possibly yield better outcomes. Overall, the long-term study confirms the fact that Avastin performs just as well as Lucentis for treating wet AMD.
"Some experts had speculated that two years of treatment with ranibizumab might have long-term benefits superior to bevacizumab," said Daniel F. Martin, M.D., study co-author and chair of the Cleveland Clinic Cole Eye Institute. "However, at five years, there were no differences in visual acuity between the two drugs."
In terms of safety, the original Lucentis patient group had after five years a higher incidence of stroke and heart attack in this study – 7.6 percent versus 4.5 percent for Avastin. Researchers cautioned that the safety results may have been affected by the fact that patients could switch drugs or use other treatments after two years.
In the end, about 20 percent of eyes had declined to 20/200 vision or worse, generally considered the threshold for legal blindness. Experts say these results highlight the need for continued research and new treatments.
"Although anti-VEGF treatment has greatly improved the prognosis for patients overall, we still need to find ways to avoid poor vision in these patients and to decrease the burden of ongoing treatment," said Maureen G. Maguire, Ph.D., lead author of the study and a professor of ophthalmology at the Perelman School of Medicine at the University of Pennsylvania.
AMD is the leading cause of legal blindness in America and Western Europe.1 It causes central vision loss, which is used for driving, reading and recognizing faces. About 10 million people in the United States have some form of AMD.2,3
"Five-Year Outcomes with Anti-VEGF Treatment of Neovascular Age-Related Macular Degeneration (AMD)," Maguire, et al. Ophthalmology, article in press, May 2016. DOI: 10.1016/j.ophtha.2016.03.045. Investigators also presented the findings today at the Association for Research in Vision and Ophthalmology conference in Seattle. The research was supported by NEI grants EY017823, EY017825, EY017826 and EY017828. For a full copy of the study, please contact the Academy Public Relations Department at email@example.com.
Learn more about macular degeneration at http://www.aao.org/eye-health/diseases/amd-macular-degeneration.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart® program provides the public with the most trusted information about eye health. For more information, visit www.aao.org.
Ophthalmology, the official journal of the American Academy of Ophthalmology, publishes original, peer-reviewed, clinically-applicable research. Topics include the results of clinical trials, new diagnostic and surgical techniques, treatment methods, technology assessments, translational science reviews and editorials. For more information, visit www.aaojournal.org.
1 Prevalence and causes of vision loss in high-income countries and in Eastern and Central Europe: 1990–2010, Bourne et al. British Journal of Ophthalmology, 2014.
2 Prevalence of Age-Related Macular Degeneration in the United States, Friedman, et al. Archives of Ophthalmology, 2004
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SOURCE American Academy of Ophthalmology