NCT01134055

Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration

MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops Versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.

Detailed description

MD7110852 is a Phase 2b dose-ranging study designed to demonstrate the 1 year efficacy and safety of pazopanib eye drops for the treatment of neovascular age related macular degeneration (AMD) in subjects whose disease is currently managed with anti-VEGF (vascular endothelial growth factor) injection therapy. Eye drop regimens are double-masked with placebo eye drops and will have access to open-label ranibizumab intravitreal (IVT) injection if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	pazopanib eye drops	A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
DRUG	placebo	placebo eye drops
BIOLOGICAL	ranibizumab intravitreal injection	Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-05-31
• Last updated: 2018-01-08
• Results posted: 2018-01-08

Locations

77 sites across 9 countries: United States, Australia, Belgium, Canada, Denmark, Germany, Italy, Japan, Sweden