NCT01512966

Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)

An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.

Conditions

• Macular Edema

Interventions

Type	Name	Description
BIOLOGICAL	VEGF Trap-Eye (BAY86-5321)	Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-01-20
• Last updated: 2014-10-09

Locations

18 sites across 1 country: Japan