NCT00637377

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 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,240 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase III, 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 Europe, Asia, Japan, Australia and South America.

Detailed description

Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab	Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered 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 (EYLEA, VEGF Trap-Eye, BAY86-5321)	Participants received a 2.0 mg dose of Aflibercept Injection administered 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 (EYLEA, VEGF Trap-Eye, BAY86-5321)	Participants received a 0.5 mg dose of Aflibercept Injection administered 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 (EYLEA, VEGF Trap-Eye, BAY86-5321)	Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-09-01
• Completion: 2011-08-01
• First posted: 2008-03-18
• Last updated: 2014-12-12
• Results posted: 2012-01-23

Locations

189 sites across 26 countries: Argentina, Australia, Austria, Belgium, Brazil, Colombia, Czechia, France, Germany, Hungary, India, Israel, Italy, Japan, Latvia, Mexico, Netherlands, Poland, Portugal, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, United Kingdom