Comparison of Ranibizumab 0.5 mg Versus 1.0 mg for the Treatment of Patients With Clinically Significant Diabetic Macular Edema: A Randomized, Clinical Trial.

BACKGROUND AND OBJECTIVE: To compare ranibizumab (Lucentis; Genentech, South San Francisco, CA) 0.5 mg and 1.0 mg for the treatment of clinically significant diabetic macular edema (CSDME). PATIENTS AND METHODS: This was a 12-month, prospective, single-masked, randomized clinical trial. Patients with CSDME secondary to diabetic retinopathy were randomized to receive 0.5 mg or 1.0 mg of ranibizumab by intravitreal injection once monthly for 3 months and then once every other month as needed. RESULTS: Patients received a mean of 6.5 injections in each group during the course of this 12-month study. The mean change in Early Treatment Diabetic Retinopathy Study visual acuity from baseline to month 12 was + 3.8 letters in the ranibizumab 0.5mg group (n = 23) and + 7.9 letters in the 1.0-mg group (n = 23; P =.92 vs. 0.5 mg). Central foveal thickness (CFT) significantly decreased from baseline to month 12 in both dose groups. CONCLUSION: Treatment of CSDME with ranibizumab resulted in a statistically significant improvement in visual acuity (ranibizumab 1.0 mg) and decrease in CFT and macular volume (ranibizumab 0.5 mg and 1.0 mg) from baseline to 12 months.