Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Visual acuity impairment caused by macular edema in at least one eye

• Type 1 or type 2 diabetes mellitus

• Stable medication of diabetes in past 3 month

Exclusion Criteria:

• Patients with uncontrolled systemic or ocular diseases

• Laser photocoagulation in the study eye for the last 3 months

• Any history of any intraocular surgery in the study eye within the past 3 months

• Blood pressure > 160/100 mmHg

Other protocol defined inclusion/exclusion criteria may apply