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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Intravitreal injection of KH902 once per month
First Affiliated Hospital of Fujian Medical College
Fuzhou, Fujian, China
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Mean change from baseline in BCVA
To evaluate the mean change from baseline in best-corrected visual acuity (BCVA) in KH902 treatment group and sham treatment group at month 3 and compare the difference between the values
Time frame: at month 3
The incidence rate of adverse event
To evaluate the difference in safety assessment between Conbercept (KH902) group and Sham group at month 3.
Time frame: at month 3
Mean change of retinal thickness from baseline
To evaluate the mean change of retinal thickness from baseline in KH902 treatment group or sham treatment group at month 3.
Time frame: at month 3
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Wuhan General Hospital of Guangzhou Military Command
Wuhan, Hubei, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Ophthalmologic Hospital of Qingdao
Qingdao, Shandong, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Daping Hospital of the Third Military Medical University
Chongqing, China
...and 1 more locations