A Crossover Design for Comparative Efficacy: A 36-Week Randomized Trial of Bevacizumab and Ranibizumab for Diabetic Macular Edema.

ABSTRACT:

Purpose

To investigate the comparative efficacy of bevacizumab (Avastin) and ranibizumab (Lucentis; both Genentech, Inc, South San Francisco, CA) for diabetic macular edema (DME) using a crossover study design.

Design

Randomized, double-masked, 36-week, 3-period crossover clinical trial.

Participants

Fifty-six subjects with DME involving the center of the macula in one or both eyes.

Methods

Monthly intravitreous injections of bevacizumab (1.25 mg) or ranibizumab (0.3 mg).

Main outcome measures

Comparison of mean changes in visual acuity and central retinal thickness, tested using a linear mixed-effects model.

Results

Based on the linear mixed-effects model, the 3-month estimated mean improvement in visual acuity was 5.3 letters for bevacizumab and

SUBMITTER: Wiley HE 

PROVIDER: S-EPMC4988394 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature