NCT00687804

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Ranibizumab	0.5 mg ranibizumab administered by intravitreal injection.
PROCEDURE	Laser	Laser photocoagulation treatment
PROCEDURE	Sham laser	Sham to laser procedure.
DRUG	Sham to ranibizumab	Sham to ranibizumab administered as an intravitreal injection.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-01-01
• Completion: 2012-01-01
• First posted: 2008-06-02
• Last updated: 2013-04-01
• Results posted: 2011-04-19

Locations

13 sites across 13 countries: Australia, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands, Spain, Switzerland, Turkey (Türkiye), United Kingdom