NCT00943072

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

A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.

Conditions

• Macular Edema Secondary to Central Retinal Vein Occlusion

Interventions

Type	Name	Description
BIOLOGICAL	VEGF Trap-Eye 2.0mg	Monthly intravitreal injection out to the Week 24 Primary endpoint
DRUG	Sham	Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-10-01
• Completion: 2012-04-01
• First posted: 2009-07-21
• Last updated: 2013-05-27
• Results posted: 2013-05-27

Locations

61 sites across 5 countries: United States, Canada, Colombia, India, Israel