NCT00383370

Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

A Trial to Assess the Safety and Tolerability of Repeated Doses of Intravitreal Administration of Two VEGF Trap Formulations in Subjects With Neovascular Age Related Macular Degeneration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.

Detailed description

A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.

Conditions

• Neovascular Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	VEGF Trap	VEGF Trap formulation 1, ITV-1
BIOLOGICAL	VEGF Trap	VEGF Trap formulation 2 at higher concentration in Open label cohort

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-09-01
• Completion: 2008-07-01
• First posted: 2006-10-03
• Last updated: 2011-04-21

Locations

6 sites across 1 country: United States