NCT01012973

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

Conditions

• Retinal Vein Occlusion

Interventions

Type	Name	Description
BIOLOGICAL	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.
OTHER	Sham treatment	Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-02-01
• Completion: 2012-02-01
• First posted: 2009-11-13
• Last updated: 2014-11-03
• Results posted: 2012-11-22

Locations

73 sites across 10 countries: Australia, Austria, France, Germany, Hungary, Italy, Japan, Latvia, Singapore, South Korea