A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study

A Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) as Adjunctive and Mono-therapy in Patients With Visual Impairment Due to Diabetic Macular Edema

CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema.

CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema.

Inclusion Criteria:

• Visual acuity impairment
• Diabetic macular edema in at least one eye
• Type 1 or type 2 diabetes mellitus
• Medication for the diabetes treatment must be stable for the last 3 months

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

Extension Inclusion Criteria:

-Completion of the Core Study