NCT01377597

Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

A 3-month, Phase III, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Monthly Intravitreal Injections as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Branch or Central Retinal Vein Occlusion (RVO)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.

Conditions

• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	ranibizumab

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-06-21
• Last updated: 2016-11-18

Locations

8 sites across 1 country: Japan