Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy

Chengdu Kanghong Biotech Co., Ltd.30 sites in 1 country200 target enrollmentApril 25, 2017

ConditionsPolypoid Choroidal Vasculopathy (PCV)

Interventionsconbercept ophthalmic injection （0.5mg）

Drugsconbercept ophthalmic injection （0.5mg）

Overview

Phase: Phase 4
Intervention: conbercept ophthalmic injection （0.5mg）
Conditions: Polypoid Choroidal Vasculopathy (PCV)
Sponsor: Chengdu Kanghong Biotech Co., Ltd.
Enrollment: 200
Locations: 30
Primary Endpoint: change of best corrected visual acuity (BCVA)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 25, 2017

End Date

February 28, 2020

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Responsible Party

Sponsor

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.

Arms & Interventions

Q12W group

Intervention: conbercept ophthalmic injection （0.5mg）

TAE group

Intervention: conbercept ophthalmic injection （0.5mg）

Outcomes

Primary Outcomes

change of best corrected visual acuity (BCVA)

Time Frame: 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

Time Frame: up to 40 week

Assess incidence and severity of adverse events in subjects.