article312

CATT

"Bevacizumab and Ranibizumab for Neovascular Age-Related Macular Degeneration (AMD)". The New England Journal of Medicine. 2011. ClinicalTrials.gov number, NCT00593450.

Clinical Question

Does bevacizumab provide similar visual outcomes to ranibizumab when used to treat neovascular age-related macular degeneration (AMD)?

Bottom Line

At 1 year, bevacizumab, when administered according to the same schedule as ranibizumab, provided equivalent effects on visual acuity in patients with neovascular AMD.

Major Points

Guidelines

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.

Design

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.

Population

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.

Interventions

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.

Outcomes

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%).

Criticisms

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.

Funding

Funded by the National Eye Institute.