Purchase this article with an account.
Diana V. Do, Peter A. Campochiaro, David S. Boyer, David Callanan, Afsheen A. Khwaja, Yasir J. Sepah, Quan D. Nguyen, READ 3 Research Group; 6 Month Results of the READ 3 Study: Ranibizumab for Edema of the mAcula in Diabetes. Invest. Ophthalmol. Vis. Sci. 2012;53(14):5282.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To describe the changes in best corrected visual acuity (BCVA) and retinal thickness in subjects with 6 month follow-up in the READ 3 study, which is a phase 2, randomized clinical trial evaluating 2.0mg and 0.5mg ranibizumab (RBZ) in eyes with center-involved diabetic macular edema (DME).
152 study eyes participated and were randomized to either 2.0mg or 0.5mg RBZ given monthly for 6 months. The primary endpoint of the study was the mean change in BCVA from baseline to month 6. After month 6, eyes were evaluated monthly and additional RBZ was administered on an as needed basis if DME was still present on optical coherence tomography (OCT).
At baseline, the mean BCVA Snellen equivalent was 20/63 in the 2.0mg RBZ group and 20/80 in the 0.5mg RBZ group. OCT central subfield thickness (CSF) was 432μm in the 2.0mg RBZ group and 441μm in the 0.5mg RBZ group. At month 6, the primary endpoint of the study, mean change in BCVA was + 7.46 ETDRS letters read in 2.0mg RBZ group and + 8.69 letters in the 0.5mg RBZ group. The CSF was reduced by -163.86μm and -169.27μm at month 6 for 2.0mg and 0.5 mg groups, respectively. There were no serious ocular or systemic adverse events related to 2.0mg or 0.5mg RBZ.
Treatment of DME with 2.0mg RBZ for 6 months provides an improvement in BCVA and reduction in CSF that is similar to 0.5mg RBZ. No safety signals were associated with 2.0mg RBZ. Additional studies and long-term analyses of the READ 3 study are needed to determine the potential role of 2.0mg RBZ in eyes with DME.
Clinical Trial: :
This PDF is available to Subscribers Only