Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose).

ABSTRACT:

Purpose

To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME) and a central subfield thickness (CFT) of ≥250 μm on time-domain optical coherence tomography.DesignRandomized, controlled, multicenter clinical trial.

Methods

Eligible eyes were randomized in a 1:1 ratio to 0.5 mg (n=77) or 2.0 mg (n=75) RBZ. Study eyes received 6-monthly injections.Main outcome measuresThe primary outcome measure was the mean change in best corrected visual acuity (BCVA) at month 6. Secondary outcomes included the incidence and severity of systemic and ocular adverse events and the mean change in CFT from baseline.

Results

In all, 152 eyes (152 patients) were randomized in the study. At month 6, the mean improvement from

SUBMITTER: Do DV 

PROVIDER: S-EPMC5129796 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature