Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Diabetic macular edema with center involvement in at least one eye

• Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening

• Laser photocoagulation in the study eye can be withheld for at least 3 months after randomization

Exclusion Criteria:

• Patients with uncontrolled systemic or ocular diseases

• Have any history of any intraocular surgery in the study eye within the past 6 months preceding screening

• Conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids

Other protocol-defined inclusion/exclusion criteria applied to the study.