Bevacizumab vs Ranibizumab: One Year Outcomes of a Head to Head, Prospective, Double-Masked, Randomized Clinical Trial

Abstract

Purpose: : To report one year outcomes of a prospective, double-masked, randomized, controlled trial comparing bevacizumab to ranibizumab for the treatment of age-related macular degeneration (AMD).

Methods: : This is a single center, prospective, double-masked, randomized controlled clinical trial at the Boston VA Healthcare System. Patients who met inclusion criteria were randomized 2:1 to bevacizumab or ranibizumab. Each patient contributed one eye to the study. All subjects and investigators (except for the pharmacist responsible for study assignments) were blinded to treatment arms. Visual acuity was checked on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Patients were given either bevacizumab or ranibizumab every month for the first 3 months, followed by optical coherence tomography-guided, variable dosing regimen. Main outcomes measured were visual acuity and foveal thickness at one year.

Results: : Eighteen patients completed one year follow-up. Eleven patients received bevacizumab and seven patients received ranibizumab. No subjects in the bevacizumab group and 1 subject in the ranibizumab group lost more than 15 letters on ETDRS chart. The average pre-operative visual acuity was 31.5 letters in the bevacizumab group, and 32.7 letters in the ranibizumab group. At one year follow-up, mean vision was 43.6 letters (20/64) in the bevacizumab group, and 39.0 letters (20/80) in the ranibizumab group (p=0.40). Central subfield thickness (CST) improved in both groups. Subjects receiving bevacizumab had a baseline CST of 288.6 microns, which improved at one year to 235.8 microns. Subjects receiving ranibizumab had a baseline CST of 340.8 microns, improving to 203.6 microns (p=0.018). Patients in the bevacizumab group underwent an average of 8.0 injections, while patients in the ranibizumab group underwent a mean of 4.2 injections.

Conclusions: : One year outcomes of a head to head, randomized, prospective, double-masked, controlled clinical trial comparing bevacizumab and ranibizumab failed to show a difference in visual outcomes for treatment of exudative age-related macular degeneration. However, a significant difference in central foveal thickness was seen, and patients in the bevacizumab group required more injections over one year. Further studies with larger sample sizes are needed in order to establish significant differences in efficacy.

Clinical Trial: : www.ISRCTN.org 73359806

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials