Investigators from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have shown, at the 6-month mark in a small group of patients, that there is no difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD). The study is the first to report early outcomes of a prospective, double-masked, randomized, controlled trial comparing Bevacizumab to Ranibizumab for the treatment of exudative (wet) age-related macular degeneration.
AMD is the leading cause of blindness over the age of 50 in developed Western countries. It can present in two forms, exudative (wet) or nonexudative (dry). While dry AMD can lead to severe vision loss, wet AMD is often more visually devastating with a higher risk of blindness. The gold standard of treatment is ranibizumab (Lucentis, Genentech Inc.), which was FDA approved for AMD in 2006. Bevacizumab (Avastin, Genentech Inc.) was FDA approved for colo-rectal cancer in 2004, and has since been used worldwide as an off-label, local intravitreal treatment for wet AMD. Both have shown to be efficacious in the treatment of AMD, however, it is unknown which one is more effective.
This study was supported with resources and the use of facilities at the Veterans Affairs Boston Healthcare System, Jamaica Plain, Mass. The VA funded the cost of medications for this study. Patients were enrolled by a 2:1 randomization to either the bevacizumab (2) or ranibizumab (1) arm of the study. Once inclusion criteria were met, patients were given intravitreal injection of bevacizumab or ranibizumab every month for the first 3 months (as they began the trial, month one, and month two). Following the third injection, patients returned for monthly examination and testing and received further injections on an as-needed basis for 1 year.
“Our study aimed to offer early, 6-month results of a randomized, double-masked, single center clinical trial comparing the off-label use of bevacizumab with the current gold standard ranibizumab. With a total of 20 subjects and a 2:1 randomization, early results of this trial suggest that at 6 months, visual outcomes of bevacizumab appear to be no different from ranibizumab,” said lead author and Principal Investigator Manju Subramanian, MD (pictured), an assistant professor in Ophthalmology at BUSM.
Illustration: Boston University School of Medicine.
Boston University School of Medicine News Release (10/13/10)
Science Daily (10/01/10)
Medical News Today (10/04/10)
Abstract (Eye; 24, 1708-1715 (11/10))