This study evaluates the efficacy and safety of Conbercept ophthalmic injection. This is a multi-center, randomized, double-masked, placebo-controlled phase III clinical study. 237 patients with central retinal vein occlusion(CRVO) are expected to be enrolled in the study and randomly assigned into the Conbercept ophthalmic injection treatment group or the control group at a ratio of 2:1.
The trial is divided into core and extension periods. 1. Core period (Day 0 - Month 5): Eligible subjects after the screening are assigned into the group to receive either intravitreal injection of Conbercept ophthalmic injection at a dose of 0.5 mg (treatment group) or a sham injection (control group) into their study eyes every month (Day 0 - Month 5). At month 6, primary endpoint are judged by investigators. 2. Extension period (Month 6 \~ 12): Subjects in treatment group are reviewed monthly, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11). Subjects in control group receive a single intravitreal injection of 0.5 mg Conbercept ophthalmic injection in month 6, followed monthly review, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11). The final evaluation is performed at the end of Month 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
242
Subject receive 0.5 mg Conbercept injection into their study eyes every month (Day 0 - Month 5). If subjects meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11).
Subjects receive sham injection into their study eyes every month (Day 0 - Month 5). Subjects receive a single intravitreal injection of 0.5 mg Conbercept ophthalmic injection in month 6, followed monthly review, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11).
Beijing Friendship Hospital,Capital Medical University
Best Corrected Visual Acuity
To compare mean changes in Best Corrected Visual Acuity (BCVA) from baseline between the Conbercept ophthalmic injection treatment group (treatment group) and the control group at month 6.
Time frame: month 6
Best Corrected Visual Acuity
To evaluate mean changes in BCVA from baseline of the treatment group and the control group at month 3 and 12.
Time frame: month 3 and month 12
Central Retinal Thickness
To evaluate mean changes in Central Retinal Thickness (CRT) from baseline of the treatment group and the control group at month 3, 6 and 12.
Time frame: month 3, month6 and month 12
Number of subject who received laser rescue treatment
To evaluate the number of subjects who received laser rescue treatment of the treatment group and the control group at month 6 and 12.
Time frame: month 6 and month 12
Number of participants with treatment-related the systemic and ocular safely as assessed
To evaluate the systemic and ocular safety of the treatment group and the control group.
Time frame: month 6 and month 12 or trail period
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Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The General Hospital of the People's Liberation Army
Beijing, China
The Second Hospital of Jilin University
Changchun, China
The Second Xiangya Hospital of Central South University
Changsha, China
West China Hospital Sichuan University
Chengdu, China
...and 17 more locations