A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients

A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients

Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.

Key Inclusion Criteria:

• Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
• Stable medication for diabetes within 3 months prior to Visit 1
• Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters

Key Exclusion Criteria:

• Stroke or myocardial infarction less than 3 months prior to screening visit
• Uncontrolled hypertension
• Active ocular infection or intraocular inflammation in any eye
• Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
• Active proliferative diabetic retinopathy in study eye
• Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
• Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
• History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening