NCT01436864

A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD

A Phase 3 Clinical Trial of Intravitreal Injections of Human Recombinant Vascular Endothelial Growth Factor Receptor-Fc Fusion Protein in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Chengdu Kanghong Biotech Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.

Detailed description

AMD is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by VEGF is the main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost. The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase II study showed that KH902 is well-tolerated,and safe, it is effective in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF. This study is designed to prove and confirm the efficacy and safety of multiple injections of KH902 in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human VEGF Receptor-Fc Fusion Protein	Intravitreal injection of KH902 once per month

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-12-01
• Completion: 2013-11-01
• First posted: 2011-09-20
• Last updated: 2023-04-18

Locations

11 sites across 1 country: China