NCT00509795

Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)

A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,217 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 3, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	ranibizumab	Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
BIOLOGICAL	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Participants received a 2.0mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
BIOLOGICAL	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Participants received a 0.5mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
BIOLOGICAL	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-09-01
• Completion: 2011-07-01
• First posted: 2007-08-01
• Last updated: 2012-12-28
• Results posted: 2012-04-16

Locations

188 sites across 2 countries: United States, Canada