Clinical trial NCT03244657: Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy
Official title: Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polypoid Choroidal Vasculopathy (PCV)
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-09
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.


Eligibility criteria: Inclusion Criteria:

* (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.

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:

* 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.

Primary outcomes:
measure: change of best corrected visual acuity (BCVA)
timeFrame: up to 40 week
measure: adverse events
timeFrame: up to 40 week
Secondary outcomes:
measure: mean of change of BCVA
timeFrame: up to 40 week
measure: change of central retinal thickness (CRT)
timeFrame: up to 40 week
measure: mean of change of lesion's maximum retinal thickness (MRT)
timeFrame: up to 40 week
measure: average number of times of drug administration
timeFrame: up to 40 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital,Cmu
city: Beijing
country: China
facility: Chinese Pla General Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People'S Hospital
city: Beijing
country: China
facility: PEKING UNIVERSITY Third HOSPITAL
city: Beijin
country: China
facility: Beijing Hospital
city: Beijin
country: China
facility: The Chinese people's liberation army 474 hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Hainan
country: China
facility: Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University
city: Hebei
country: China
facility: Hebei Eye Hospital
city: Hebei
country: China
facility: The Second Hospital of Hebei Medical University
city: Henan
country: China
facility: Henan Province People's Hospital
city: Jilin
country: China
facility: The Second Hospital of Jilin University
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
city: Nanchang
country: China
facility: Affiliated Eye Hospital of Nanchang University
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: The First Affiliated Hospital With Nanjing Medical University
city: Shanghai
country: China
facility: Eye&Ent Hospital of Fudan University
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shantou
country: China
facility: Stu/Cuhk Joint Shantou International Eye Center
city: Shanxi
country: China
facility: Shanxi Eye Hospital
city: Shenzhen
country: China
facility: Shenzhen Eye Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
city: Wenzhou
country: China
facility: The Eye Hospital of Wmu Zhejiang Eye Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Xiamen
country: China
facility: Xiamen Eye Centre of Xiamen University
city: Yinchuan
country: China
facility: Ningxia Peple'S Hospital
city: Zhejiang
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
Study officials:
References: