"Bevacizumab and Ranibizumab for Neovascular Age-Related Macular Degeneration (AMD)". The New England Journal of Medicine. 2011. ClinicalTrials.gov number, NCT00593450.
Links to original sources: Wiki Journal Post Full Journal Article
Does bevacizumab provide similar visual outcomes to ranibizumab when used to treat neovascular age-related macular degeneration (AMD)?
At 1 year, bevacizumab, when administered according to the same schedule as ranibizumab, provided equivalent effects on visual acuity in patients with neovascular AMD.
Bevacizumab is used off-label to treat neovascular AMD due to its low cost and similar target specificity to the approved drug ranibizumab. The Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) study was designed to assess the relative efficacy and safety of the two drugs and various dosing regimens. The study found that visual acuity outcomes for bevacizumab were equivalent to those for ranibizumab whether administered monthly or as needed. There was a higher rate of serious systemic adverse events reported with bevacizumab (24.1% vs. 19.0% with ranibizumab), but the analysis did not show statistical significance for individual categories of adverse events.
Current guidelines differentiate these agents primarily based on their FDA approval status, with ranibizumab being approved and bevacizumab being used off-label for neovascular AMD. Ongoing studies and comparison will aid in further guideline development.
Multicenter, single-blind, noninferiority trial of 1208 patients randomly assigned to four groups: ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, bevacizumab as needed. The primary outcome was the mean change in visual acuity at 1 year.
Patients were 50 years or older with neovascular AMD in one eye, with visual acuity between 20/25 and 20/320, and previously untreated active choroidal neovascularization.
Ranibizumab (0.50 mg) or bevacizumab (1.25 mg) was administered intravitreally. Patients received injections either monthly or as needed based on signs of active neovascularization.
The mean change in visual acuity at 1 year was equivalent between drugs when administered monthly or as needed. Ranibizumab as needed was equivalent to ranibizumab monthly, but equivalence was inconclusive for bevacizumab as needed versus monthly. Rates of death, myocardial infarction, and stroke were similar for patients receiving bevacizumab or ranibizumab. There was a higher proportion of patients with serious systemic adverse events reported with bevacizumab (24.1% vs. 19.0%).
The trial was designed as noninferiority, limiting the ability to detect small but potentially clinically meaningful differences. The higher rate of serious systemic adverse events with bevacizumab could be due to chance, imbalances at baseline, or a true risk difference, necessitating further investigation.
Funded by the National Eye Institute.
The full article is available at NEJM.org (10.1056/NEJMoa1102673).