Conditions: Macular Degeneration
Keywords: ranibizumab wet AMD MD7110852 age related macular degeneration age-related macular degeneration macular degeneration pazopanib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 510
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection arm 2: 5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection arm 3: 10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection arm 4: 10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection arm 5: 10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection arm 6: Placebo eye drops QID with allowance for as-needed ranibizumab injection arm 7: Ranibizumab intravitreal injection every 4 weeks

Interventions: intervention 1: pazopanib eye drops intervention 2: placebo intervention 3: ranibizumab intravitreal injection
Intervention descriptions: intervention 1: A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors. intervention 2: placebo eye drops intervention 3: Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A

Protocol document: