NCT00789477

DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Detailed description

Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
PROCEDURE	Laser Photocoagulation	laser every 16 weeks as needed
DRUG	Intravitreal Aflibercept Injection

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-12-01
• Completion: 2010-09-01
• First posted: 2008-11-11
• Last updated: 2014-09-09
• Results posted: 2014-09-09

Locations

47 sites across 3 countries: United States, Austria, Canada