NCT00320814

Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema

An Exploratory Study of the Safety, Tolerability and Biological Effect of a Single Intravitreal Administration of VEGF Trap in Patients With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.

Detailed description

This is an open label study. Initially, 5 patients with DME will receive an ITV injection of VEGF Trap into the study eye. Additional patients may be enrolled at the same or additional dose levels. Patients will be observed for six weeks following the injection for assessments of ocular and systemic safety.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	VEGF Trap-Eye	single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-08-01
• Completion: 2007-08-01
• First posted: 2006-05-03
• Last updated: 2011-06-10

Locations

2 sites across 1 country: United States