This study is designed to access the safety and efficacy of multiple injections of KH902 in patients with Diabetic Macular Edema (DME).
With improvement of our living standard, patients who suffered from Diabetes become more and more. As the investigators know, Diabetes can induce many ocular diseases leading to vision loss. And according to observations, DME is diagnosed as one main cause of vision loss in the patients with Diabetes. As the results of many studies conducted previously, anti-VEGF drugs and anti-VEGF treatments show its effect and safety not only in treating AMD, but also in patients with DME. The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The previous clinical trials of KH902 show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF. Due to these positive results, the investigators prepare to conduct a clinical trial to assess the safety and efficacy with intravitreal injection of KH902 in patients with DME.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravitreal injection of 0.5mg/eye/time KH902
Shanghai First People's Hospital
Shanghai, China
Incidence rate of adverse event
To evaluate the safety of multiple intravitreal injection of KH902 to treat DME.
Time frame: up to 12 months
Change from Baseline in BCVA
To evaluate the efficacy of multiple intravitreal injection of KH902 of each group.
Time frame: at the end of month 3 and the end of month 12
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