This study is designed to assess safety and efficacy of intravitreal injection of Conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
248
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
Sham intravitreal injection at first month, then repeated as needed.
Laser treatment at first month, then repeated as needed.
Peking University People's Hospital
Beijing, Beijing Municipality, China
COMPLETEDMean change from baseline in best corrected visual acuity (BCVA) at month 12
To compare mean change from baseline BCVA between treatment group and controlled group at month 12.
Time frame: Baseline and month 12
Mean change from baseline in central retinal thickness (CRT) between two groups
To compare mean change from baseline CRT between two groups at month 12.
Time frame: Baseline and month 12
Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection
To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc.
Time frame: 12 months
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Sham laser at first month, then repeated as needed.
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGSouthwest Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGDaping Hospital, Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGZhongshan Ophthalmic Center , Sun Yat-Sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGEye hospital of Henan province
Zhengzhou, Henan, China
RECRUITINGWuhan General Hospital of Guangzhou Military
Wuhan, Hubei, China
RECRUITINGWuxi No.2 People's Hospital
Wuxi, Jiangsu, China
RECRUITINGHe eye hospital
Shenyang, Liaoning, China
RECRUITING...and 7 more locations