Researchers from Boston University School of Medicine ( BUSM ) and the VA Boston Healthcare System have shown, at 6 months 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, which is published in the American Journal of Ophthalmology, is the first to report early outcomes of a prospective, double-masked, randomized, controlled trial comparing Bevacizumab to Ranibizumab for the treatment of wet ( exudative ) age-related macular degeneration.
Age-related macular degeneration is the leading cause of blindness over the age of 50 in developed Western countries. It can present in 2 forms, exudative or non-exudative. While non-exudative AMD can lead to severe vision loss, exudative AMD is often more visually devastating with a higher risk of blindness.
The gold standard of treatment is Ranibizumab, which was FDA approved for age-related macular degeneration in 2006.
Bevacizumab 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 age-related macular degeneration, however, it is unknown which one is more effective.
Patients were enrolled by a 2:1 randomization to either the Bevacizumab or Ranibizumab arm of the study. Once inclusion criteria were met, patients were given intravitreal injection of Bevacizumab or Ranibizumab every month for the first three 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 one year.
With a total of 20 subjects early results of this trial suggest that at 6 months, visual outcomes of Bevacizumab appear to be no different from Ranibizumab.
Genentech Pharmaceuticals ( the manufacturer of both drugs ) has refused to sponsor a head to head trial comparing the two treatments. The open market cost of a single injection of Lucentis is approximately $2000.00. Comparatively, the cost of a single injection of Avastin for AMD is $40.00. Patients potentially undergo up to 13 injections per year, leading to a large cost differentiation for treatment of this common eye disease.
The National Eye Institute is sponsoring the Comparison of AMD Treatment Trials Study ( CATT Study ), a multicenter, randomized, double-masked, clinical trial designed to assess the efficacy of Bevacizumab compared to Ranibizumab therapy and will be conducted in 44 clinical Centers throughout the United States.
Source: Boston University Medical Center, 2009