NCT01396083

Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)

A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Central Retinal Vein Occlusion (CRVO)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.

Conditions

• Visual Impairment
• Macular Edema
• Central Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Ranibizumab
DRUG	Dexamethasone implant and sham injections

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-07-18
• Last updated: 2016-09-27
• Results posted: 2015-02-18

Locations

64 sites across 4 countries: Germany, Hungary, Poland, United Kingdom