Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy
- Conditions
- Polypoid Choroidal Vasculopathy (PCV)
- Interventions
- Registration Number
- NCT03244657
- Lead Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Brief Summary
To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- (1) Sign the informed consent and be willing to receive follow-up at the time specified in the trial; (2) A subject who has completed all visits specified by STAR study protocol and who is within 3 months after end of the last visit (the following subjects can be included: during STAR study, an investigator decided to discontinue treatment from point of view of safety, but the risk factor has disappeared or become stable).
Note: Use the determined eye of STAR study as the target eye.
-
(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:
- Sterilization (male with bilateral vasoligation, vasectomy)
- Hormone contraception (implantable type, patch type, oral administration type)
- Intrauterine device, double-barrier method IV. Be able to take reliable contraceptive measure throughout the study and insist on it till 30 days after discontinuation of the investigational drug (unacceptable contraceptive methods include: regular abstinence, i.e., depending on calendar, ovulatory period, body temperature measurement method and post-ovulation period method; coitus interruptus for extracorporeal spermiation). (7) Pregnant (in this trial, pregnancy is defined as positive urine pregnancy test), lactating females (8) A subject whom an investigator thinks needs to be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Q12W group conbercept ophthalmic injection （0.5mg） - TAE group conbercept ophthalmic injection （0.5mg） -
- Primary Outcome Measures
Name Time Method change of best corrected visual acuity (BCVA) up to 40 week 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;
adverse events up to 40 week Assess incidence and severity of adverse events in subjects.
- Secondary Outcome Measures
Name Time Method mean of change of BCVA up to 40 week 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
change of central retinal thickness (CRT) up to 40 week 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;
mean of change of lesion's maximum retinal thickness (MRT) up to 40 week 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;
average number of times of drug administration up to 40 week Assess average number of times of drug administration in two groups of subjects during the extension treatment;
Trial Locations
- Locations (30)
Peking Union Medical College Hospital
🇨🇳Beijing, China
The Second Hospital of Jilin University
🇨🇳Jilin, China
Chinese Pla General Hospital
🇨🇳Beijing, China
Hebei Eye Hospital
🇨🇳Hebei, China
The Second Hospital of Hebei Medical University
🇨🇳Hebei, China
Eye&Ent Hospital of Fudan University
🇨🇳Shanghai, China
Stu/Cuhk Joint Shantou International Eye Center
🇨🇳Shantou, China
Shanxi Eye Hospital
🇨🇳Shanxi, China
Shenzhen Eye Hospital
🇨🇳Shenzhen, China
Tianjin Medical University Eye Hospital
🇨🇳Tianjin, China
The Eye Hospital of Wmu Zhejiang Eye Hospital
🇨🇳Wenzhou, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, China
Shanghai General Hospital
🇨🇳Shanghai, China
Affiliated Eye Hospital of Nanchang University
🇨🇳Nanchang, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, China
Xiamen Eye Centre of Xiamen University
🇨🇳Xiamen, China
Ningxia Peple'S Hospital
🇨🇳Yinchuan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Zhejiang, China
Peking University People'S Hospital
🇨🇳Beijing, China
Beijing Tongren Hospital,Cmu
🇨🇳Beijing, China
PEKING UNIVERSITY Third HOSPITAL
🇨🇳Beijing, China
Beijing Hospital
🇨🇳Beijin, China
The Chinese people's liberation army 474 hospital
🇨🇳Beijin, China
Henan Province People's Hospital
🇨🇳Henan, China
Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Hainan, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
Renji Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanjing, China
The First Affiliated Hospital With Nanjing Medical University
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing, China