NCT00989989

Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Ranibizumab	Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.
PROCEDURE	Laser photocoagulation	Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.
DRUG	Sham ranibizumab	Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.
PROCEDURE	Sham laser photocoagulation	Sham laser treatment administered at day 1.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2009-10-06
• Last updated: 2012-10-18
• Results posted: 2012-10-18

Locations

35 sites across 6 countries: China, Hong Kong, Japan, Singapore, South Korea, Taiwan