Sophie J. Bakri, M.D., with the Department of Ophthalmology at Mayo Clinic in Rochester, Minn., and study principal investigator at Mayo Clinic, discusses first-year results from the National Eye Institute–funded study of neovascular age-related macular degeneration (AMD).
Findings indicate that bevacizumab (Avastin), a drug commonly used off label to treat new blood vessel growth due to wet AMD, is as effective as ranibizumab (Lucentis) for the treatment of AMD when given at the same dosing schedule.
An article about the study was published in the May 19, 2011 issue of The New England Journal of Medicine.
Read “Bevacizumab Expands Treatment Options for Patients With Age-Related Macular Degeneration” in Ophthalmology Update.
ABSTRACT
Background
Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data.
Methods
A multicenter, single-blind, noninferiority trial randomly assigned 1,208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at one year, with a noninferiority limit of five letters on the eye chart.
Results
Bevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively.
Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively.
Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive.
The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance).
Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20).
The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1 percent vs. 19.0 percent; risk ratio, 1.29; 95 percent confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern.
Conclusions
At one year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study.
