NCT00320788

Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD. The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Detailed description

This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period. After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
BIOLOGICAL	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
BIOLOGICAL	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
BIOLOGICAL	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
BIOLOGICAL	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-06-01
• Completion: 2008-08-01
• First posted: 2006-05-03
• Last updated: 2012-03-01
• Results posted: 2012-03-01

Locations

18 sites across 1 country: United States