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To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q12W group | Experimental |
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| TAE group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conbercept ophthalmic injection (0.5mg) | Drug | The target eye receives intravitreal injection of 0.5mg conbercept ophthalmic injection once every 12 weeks; if a subject meets "additional drug administration criteria" within 12 weeks between treatments, the subject can receive additional injection treatment |
| Measure | Description | Time Frame |
|---|---|---|
| change of best corrected visual acuity (BCVA) | Assess mean of change of best corrected visual acuity (BCVA) compared with baseline in the target eyes (using the same target eyes as STAR study) of subjects at end of the extension study; | up to 40 week |
| adverse events | Assess incidence and severity of adverse events in subjects. | up to 40 week |
| Measure | Description | Time Frame |
|---|---|---|
| mean of change of BCVA | Assess mean of change of BCVA compared with that in STAR study baseline (before treatment) in the target eyes of subjects at end of the extension study | up to 40 week |
| change of central retinal thickness (CRT) |
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Inclusion Criteria:
Note: Use the determined eye of STAR study as the target eye.
Exclusion Criteria:
(1) A subject who actively withdrew from the study during STAR study; (2) The target eye or the body ever received other anti-VEGF drugs (such as Macugen, Lucentis, Avastin, Eylea, Zaltrap, etc.) from start of STAR study to before screening of this study.
(3) In the target eye or the body, there is any following disease and condition: an investigator thinks that if the subject participates in this study, the disease and condition (such as: the target eye has history of vitrectomy; blood pressure control of a hypertension patient is not ideal [ after treatment of antihypertensive drugs, blood pressure is still ≥ 150/95 mmHg]; AIDS; malignant tumors; active hepatitis; renal failure; severe mental, neurological, cardiovascular, respiratory and other systemic diseases; ankylosing spondylitis; systemic lupus erythematosus; heart stent surgery; and the like) may cause the subject to be at relatively large risk; (4) A subject who ever had stroke, transient ischemic attack, myocardial infarction, or acute congestive heart failure and other cardiovascular events within 6 months before screening (5) A subject who participated in any drug (not including vitamins or minerals) clinical trial within 3 months (if the test drug has long half-life and 5 half-lives > 3 months, then 5 half-lives are taken) before screening;(6) Not take effective contraceptive measure; Note: The following conditions are not excluded. I. Amenorrhea for 12 months under natural condition; or, under natural condition, amenorrhea for 6 months, accompanied with follicle stimulating hormone level in serum > 40 mIU/ml; II. 6 weeks after bilateral oophorectomy with/without hysterectomy;
III. Use one or more of the following contraceptive methods:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li xiaoxing | Contact | +86-13801153661 | dr_lixiaoxin@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Not yet recruiting | Beijin | China |
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| conbercept ophthalmic injection (0.5mg) | Drug | In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on "treatment-extension drug administration criteria", an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets "additional drug administration criteria", additional injection treatment can be given. |
|
Assess mean of change of central retinal thickness (CRT) compared with baseline in the target eyes of subjects at time of each visit till end of the extension study;
| up to 40 week |
| mean of change of lesion's maximum retinal thickness (MRT) | Assess mean of change of lesion's maximum retinal thickness (MRT), retinal pigment epithelium detachment's (PED) volume and thickness, polypoid lesion area, retinal hemorrhage area and other imaging indicators compared with baseline in the target eyes of subjects at end of the extension study; | up to 40 week |
| average number of times of drug administration | Assess average number of times of drug administration in two groups of subjects during the extension treatment; | up to 40 week |
| The Chinese people's liberation army 474 hospital | Not yet recruiting | Beijin | China |
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| Beijing Tongren Hospital,Cmu | Not yet recruiting | Beijing | China |
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| Chinese Pla General Hospital | Not yet recruiting | Beijing | China |
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| Peking Union Medical College Hospital | Not yet recruiting | Beijing | China |
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| Peking University First Hospital | Not yet recruiting | Beijing | China |
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| Peking University People'S Hospital | Recruiting | Beijing | China |
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| PEKING UNIVERSITY Third HOSPITAL | Not yet recruiting | Beijing | China |
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| Xiangya Hospital Central South University | Not yet recruiting | Changsha | China |
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| Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University | Not yet recruiting | Hainan | China |
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| Hebei Eye Hospital | Not yet recruiting | Hebei | China |
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| The Second Hospital of Hebei Medical University | Not yet recruiting | Hebei | China |
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| Henan Province People's Hospital | Not yet recruiting | Henan | China |
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| The Second Hospital of Jilin University | Not yet recruiting | Jilin City | China |
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| Lanzhou University Second Hospital | Not yet recruiting | Lanzhou | China |
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| Affiliated Eye Hospital of Nanchang University | Not yet recruiting | Nanchang | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanjing | China |
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| The First Affiliated Hospital With Nanjing Medical University | Not yet recruiting | Nanjing | China |
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| Eye&Ent Hospital of Fudan University | Not yet recruiting | Shanghai | China |
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| Renji Hospital Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | China |
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| Shanghai General Hospital | Not yet recruiting | Shanghai | China |
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| Stu/Cuhk Joint Shantou International Eye Center | Not yet recruiting | Shantou | China |
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| Shanxi Eye Hospital | Not yet recruiting | Shanxi | China |
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| Shenzhen Eye Hospital | Not yet recruiting | Shenzhen | China |
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| Tianjin Medical University Eye Hospital | Not yet recruiting | Tianjin | China |
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| The Eye Hospital of Wmu Zhejiang Eye Hospital | Not yet recruiting | Wenzhou | China |
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| Renmin Hospital of Wuhan University | Not yet recruiting | Wuhan | China |
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| Xiamen Eye Centre of Xiamen University | Not yet recruiting | Xiamen | China |
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| Ningxia Peple'S Hospital | Recruiting | Yinchuan | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Zhejiang | China |
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