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

A Randomized, Double-masked, Multi-center, Phase II Study Assessing the Safety and Efficacy of Two Concentrations of Ranibizumab (Intravitreal Injections) Compared With Non-treatment Control for the Treatment of Diabetic Macular Edema With Center Involvement

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

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.