Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy
1 other identifier
interventional
200
1 country
30
Brief Summary
To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2017
Typical duration for phase_4
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2017
CompletedFirst Submitted
Initial submission to the registry
August 7, 2017
CompletedFirst Posted
Study publicly available on registry
August 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedAugust 9, 2017
July 1, 2017
2.5 years
August 7, 2017
August 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
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
Study Arms (2)
Q12W group
EXPERIMENTALTAE group
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Beijing Hospital
Beijin, China
The Chinese people's liberation army 474 hospital
Beijin, China
Beijing Tongren Hospital,Cmu
Beijing, China
Chinese Pla General Hospital
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
Xiangya Hospital Central South University
Changsha, China
Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University
Hainan, China
Hebei Eye Hospital
Hebei, China
The Second Hospital of Hebei Medical University
Hebei, China
Henan Province People's Hospital
Henan, China
The Second Hospital of Jilin University
Jilin, China
Lanzhou University Second Hospital
Lanzhou, China
Affiliated Eye Hospital of Nanchang University
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanjing, China
The First Affiliated Hospital With Nanjing Medical University
Nanjing, China
Eye&Ent Hospital of Fudan University
Shanghai, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
Shanghai General Hospital
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
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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2017
First Posted
August 9, 2017
Study Start
April 25, 2017
Primary Completion
October 31, 2019
Study Completion
February 28, 2020
Last Updated
August 9, 2017
Record last verified: 2017-07