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

• Status: Completed
• Trial end date: 2017-01-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ranibizumab

Criteria

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