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

August 7, 2017 updated by: Chengdu Kanghong Biotech Co., Ltd.
To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijin, China
        • Not yet recruiting
        • Beijing Hospital
      • Beijin, China
        • Not yet recruiting
        • The Chinese people's liberation army 474 hospital
        • Contact:
          • Xiao Yun
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Li Xiaoxin
      • Beijing, China
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
          • Dou Hongliang
      • Beijing, China
        • Not yet recruiting
        • Peking University first hospital
      • Beijing, China
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Chen Youxin
      • Beijing, China
        • Not yet recruiting
        • Beijing Tongren Hospital,Cmu
        • Contact:
          • Zhang feng
      • Beijing, China
        • Not yet recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Li Chaohui
      • Changsha, China
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • XU Huizuo
      • Hainan, China
        • Not yet recruiting
        • Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
          • Cheng Wangling
      • Hebei, China
        • Not yet recruiting
        • Hebei Eye Hospital
        • Contact:
          • Zhang Minglian
      • Hebei, China
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
          • Ma Jingxue
      • Henan, China
        • Not yet recruiting
        • Henan province people's hospital
        • Contact:
          • Fan Ke
      • Jilin, China
        • Not yet recruiting
        • The Second Hospital of Jilin University
        • Contact:
          • Su Guanfang
      • Lanzhou, China
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
          • Zhang Wenfang
      • Nanchang, China
        • Not yet recruiting
        • Affiliated Eye Hospital of Nanchang University
        • Contact:
          • Yi Jinglin
      • Nanjing, China
        • Not yet recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
          • Liu Qinghuai
      • Nanjing, China
        • Not yet recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Zhou Qiong
      • Shanghai, China
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
          • Yu Suqin
      • Shanghai, China
        • Not yet recruiting
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • Contact:
          • Liu Lin
      • Shanghai, China
        • Not yet recruiting
        • Eye&Ent Hospital of Fudan University
        • Contact:
          • Zhang Yongjin
      • Shantou, China
        • Not yet recruiting
        • Stu/Cuhk Joint Shantou International Eye Center
        • Contact:
          • Cheng Weiqi
      • Shanxi, China
        • Not yet recruiting
        • Shanxi Eye Hospital
        • Contact:
          • Jia Yading
      • Shenzhen, China
        • Not yet recruiting
        • Shenzhen Eye Hospital
        • Contact:
          • Cheng Qingshan
      • Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University Eye Hospital
        • Contact:
          • Li Xiaorong
      • Wenzhou, China
        • Not yet recruiting
        • The Eye Hospital of Wmu Zhejiang Eye Hospital
        • Contact:
          • Liu Xiaoling
      • Wuhan, China
        • Not yet recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
          • Xing Yiqiao
      • Xiamen, China
        • Not yet recruiting
        • Xiamen Eye Centre of Xiamen University
        • Contact:
          • Wu Guoji
      • Yinchuan, China
        • Recruiting
        • Ningxia Peple'S Hospital
        • Contact:
          • Ha Shaoping
      • Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Yao ke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Q12W group
Drug: conbercept ophthalmic injection （0.5mg）
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
Drug: conbercept ophthalmic injection （0.5mg）
In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on "treatment-extension drug administration criteria", an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets "additional drug administration criteria", additional injection treatment can be given.
EXPERIMENTAL: TAE group
Drug: conbercept ophthalmic injection （0.5mg）
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
Drug: conbercept ophthalmic injection （0.5mg）
In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on "treatment-extension drug administration criteria", an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets "additional drug administration criteria", additional injection treatment can be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
up to 40 week
adverse events
Time Frame: up to 40 week
Assess incidence and severity of adverse events in subjects.
up to 40 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean of change of BCVA
Time Frame: 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
up to 40 week
change of central retinal thickness (CRT)
Time Frame: 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;
up to 40 week
mean of change of lesion's maximum retinal thickness (MRT)
Time Frame: 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;
up to 40 week
average number of times of drug administration
Time Frame: up to 40 week
Assess average number of times of drug administration in two groups of subjects during the extension treatment;
up to 40 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2017

Primary Completion (ANTICIPATED)

October 31, 2019

Study Completion (ANTICIPATED)

February 28, 2020

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (ACTUAL)

August 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KH902-STE-CRP-1.2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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