This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
176
intravitreal injection of 0.5 mg conbercept per month, fixed injection
intravitreal injection of 0.5 mg conbercept as need, PRN
sham intravitreal injection per month, fixed injection
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Tongren hospital affiliated to Capital Medical University
mean change from baseline of visual acuity
to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3
Time frame: 3-month
mean change from baseline of anatomical features
to compare the difference of mean change from baseline of CRT, CNV size and lesion size between conbercept treatment group and sham injection group at month 3
Time frame: 3-month
mean change from baseline of visual acuity
to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9
Time frame: 9 months
safety and tolerability of conbercept
to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9
Time frame: 3-month and 9-month
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Beijing, Beijing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
Daping Hospital, Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality, China
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Wuhan General Hospital of Guangzhou Military
Wuhan, Hubei, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
Ophthalmologic Hospital of Qingdao
Qingdao, Shandong, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
...and 3 more locations