NCT03244657Unknown4 期
Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy
Chengdu Kanghong Biotech Co., Ltd.30 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年4月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 30
- 主要终点
- change of best corrected visual acuity (BCVA)
研究概览
简要总结
To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
Q12W group
Experimental
干预措施: conbercept ophthalmic injection （0.5mg） (Drug)
TAE group
Experimental
干预措施: conbercept ophthalmic injection （0.5mg） (Drug)
结局指标
主要结局
change of best corrected visual acuity (BCVA)
时间窗: 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
时间窗: up to 40 week
Assess incidence and severity of adverse events in subjects.
次要结局
- mean of change of BCVA(up to 40 week)
- change of central retinal thickness (CRT)(up to 40 week)
- mean of change of lesion's maximum retinal thickness (MRT)(up to 40 week)
- average number of times of drug administration(up to 40 week)
研究者
研究点 (30)
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