Neovascular Age-related Macular Degeneration Clinical Trial
Official title:
A Randomized, Double-masked, Multicenter, Controlled Dose- and Interval-ranging Clinical Study of Intravitreal Injection of KH902 in Patients With Neovascular Age-related Macular Degeneration (the AURORA Study)
This study is designed to access the safety and efficacy of multiple injections of KH902 at variable dosing regimens in patients with CNV due to neovascular AMD.
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 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 I study show that KH902 is effective and safe
in inhibiting the growth, migration, pullulation of vascular endothelial cells and
neovascularization induced by VEGF.
This study is designed to confirm the efficacy and safety of multiple injections of KH902 at
variable dosing regimen in patients with CNV due to neovascular AMD. Based on the
characteristics of KH902 and results from KH902 Phase I study as well as reference to
clinical trials of similar drugs, it is determined that KH902 is administrated at
0.5mg/eye/time and 2.0mg/eye/time.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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