The study is believed to be the first study to describe one-year outcomes of a prospective, double-masked, randomized clinical trial directly comparing bevacizumab to ranibizuamab.
AMD is the leading cause of blindness over the age of 50 in developed Western countries. It presents in two forms, exudative (wet) or nonexudative (dry). Wet AMD is often more visually devastating with a higher risk of blindness. The gold standard of treatment for wet AMD is ranibizumab which was FDA approved as an eye injection in 2006. Bevacizumab was FDA approved for the treatment of colorectal cancer in 2004, but has also been used worldwide in an off-label fashion as an eye injection for the treatment of wet AMD.
In this study, patients were enrolled by a 2:1 ratio to receive either the ranibizumab or bevacizumab. Patients were given eye injections every month for the first three months, followed by monthly examination and testing. They received further injections on an as needed basis for one year.
Fifteen patients received bevacizumab and seven patients received ranibizuamab. There was no significant difference in visual acuity and anatomic outcomes between the two groups. Both groups had an average improvement in vision of 1.5 lines on the vision testing chart, and only one patient (who was in the ranibizuamab group) lost a significant amount of vision (three lines or more). In addition, patients in the bevacizumab group underwent an average of eight injections over one year, while patients in the ranibizuamab group underwent an average of four injections.
"With the exception that total injections given to subjects over one year were significantly different between the two treatment arms, visual and anatomic outcomes at one year failed to show a significant difference between both groups," said lead author and Principal Investigator Manju Subramanian, MD, an assistant professor in Ophthalmology at BUSM. According to the authors, further studies with larger sample sizes are warranted.
MEDICA.de; Source: Boston University Medical Center