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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Novartis
• Treatments: Ranibizumab

Criteria

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