Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema

A 12-months, Randomized, VA-assessor Blinded, Multicenter, Controlled Phase IV Trial to Investigate Noninferiority of Two Treatment Algorithms (Discretion of the Investigator vs. Pro re Nata) of 0.5 mg Ranibizumab in Patients With Visual Impairment Due to Diabetic Macula Edema

The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).

Inclusion Criteria:

• Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
• Patients with visual impairment due to DME in at least one eye
• BCVA ≥ 24 and ≤ 78 letters in the study eye

Exclusion Criteria:

• Active intraocular inflammation
• Any active infection in either eye at the
• Structural damage within 0.5 disc diameter of the center of the macula in the study eye
• Uncontrolled glaucoma in either eye at screening

Other protocol-defined inclusion/exclusion criteria may apply.