<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03244657</url>
  </required_header>
  <id_info>
    <org_study_id>KH902-STE-CRP-1.2</org_study_id>
    <nct_id>NCT03244657</nct_id>
  </id_info>
  <brief_title>Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy</brief_title>
  <official_title>Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu Kanghong Biotech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu Kanghong Biotech Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term&#xD;
      treatment of polypoid choroidal vasculopathy (PCV) subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of best corrected visual acuity (BCVA)</measure>
    <time_frame>up to 40 week</time_frame>
    <description>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;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adverse events</measure>
    <time_frame>up to 40 week</time_frame>
    <description>Assess incidence and severity of adverse events in subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean of change of BCVA</measure>
    <time_frame>up to 40 week</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of central retinal thickness (CRT)</measure>
    <time_frame>up to 40 week</time_frame>
    <description>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;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean of change of lesion's maximum retinal thickness (MRT)</measure>
    <time_frame>up to 40 week</time_frame>
    <description>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;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average number of times of drug administration</measure>
    <time_frame>up to 40 week</time_frame>
    <description>Assess average number of times of drug administration in two groups of subjects during the extension treatment;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Polypoid Choroidal Vasculopathy (PCV)</condition>
  <arm_group>
    <arm_group_label>Q12W group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TAE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>conbercept ophthalmic injection （0.5mg）</intervention_name>
    <description>The target eye receives intravitreal injection of 0.5mg conbercept ophthalmic injection once every 12 weeks; if a subject meets &quot;additional drug administration criteria&quot; within 12 weeks between treatments, the subject can receive additional injection treatment</description>
    <arm_group_label>Q12W group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>conbercept ophthalmic injection （0.5mg）</intervention_name>
    <description>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 &quot;treatment-extension drug administration criteria&quot;, 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 &quot;additional drug administration criteria&quot;, additional injection treatment can be given.</description>
    <arm_group_label>TAE group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) Sign the informed consent and be willing to receive follow-up at the time&#xD;
             specified in the trial; (2) A subject who has completed all visits specified by STAR&#xD;
             study protocol and who is within 3 months after end of the last visit (the following&#xD;
             subjects can be included: during STAR study, an investigator decided to discontinue&#xD;
             treatment from point of view of safety, but the risk factor has disappeared or become&#xD;
             stable).&#xD;
&#xD;
        Note: Use the determined eye of STAR study as the target eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) A subject who actively withdrew from the study during STAR study; (2) The target&#xD;
             eye or the body ever received other anti-VEGF drugs (such as Macugen, Lucentis,&#xD;
             Avastin, Eylea, Zaltrap, etc.) from start of STAR study to before screening of this&#xD;
             study.&#xD;
&#xD;
             (3) In the target eye or the body, there is any following disease and condition: an&#xD;
             investigator thinks that if the subject participates in this study, the disease and&#xD;
             condition (such as: the target eye has history of vitrectomy; blood pressure control&#xD;
             of a hypertension patient is not ideal [ after treatment of antihypertensive drugs,&#xD;
             blood pressure is still ≥ 150/95 mmHg]; AIDS; malignant tumors; active hepatitis;&#xD;
             renal failure; severe mental, neurological, cardiovascular, respiratory and other&#xD;
             systemic diseases; ankylosing spondylitis; systemic lupus erythematosus; heart stent&#xD;
             surgery; and the like) may cause the subject to be at relatively large risk; (4) A&#xD;
             subject who ever had stroke, transient ischemic attack, myocardial infarction, or&#xD;
             acute congestive heart failure and other cardiovascular events within 6 months before&#xD;
             screening (5) A subject who participated in any drug (not including vitamins or&#xD;
             minerals) clinical trial within 3 months (if the test drug has long half-life and 5&#xD;
             half-lives &gt; 3 months, then 5 half-lives are taken) before screening;(6) Not take&#xD;
             effective contraceptive measure; Note: The following conditions are not excluded. I.&#xD;
             Amenorrhea for 12 months under natural condition; or, under natural condition,&#xD;
             amenorrhea for 6 months, accompanied with follicle stimulating hormone level in serum&#xD;
             &gt; 40 mIU/ml; II. 6 weeks after bilateral oophorectomy with/without hysterectomy;&#xD;
&#xD;
        III. Use one or more of the following contraceptive methods:&#xD;
&#xD;
          -  Sterilization (male with bilateral vasoligation, vasectomy)&#xD;
&#xD;
          -  Hormone contraception (implantable type, patch type, oral administration type)&#xD;
&#xD;
          -  Intrauterine device, double-barrier method IV. Be able to take reliable contraceptive&#xD;
             measure throughout the study and insist on it till 30 days after discontinuation of&#xD;
             the investigational drug (unacceptable contraceptive methods include: regular&#xD;
             abstinence, i.e., depending on calendar, ovulatory period, body temperature&#xD;
             measurement method and post-ovulation period method; coitus interruptus for&#xD;
             extracorporeal spermiation). (7) Pregnant (in this trial, pregnancy is defined as&#xD;
             positive urine pregnancy test), lactating females (8) A subject whom an investigator&#xD;
             thinks needs to be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Li xiaoxing</last_name>
    <phone>+86-13801153661</phone>
    <email>dr_lixiaoxin@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Tongren Hospital,Cmu</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhang feng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chinese Pla General Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Li Chaohui</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chen Youxin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yang Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University People'S Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Xiaoxin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>PEKING UNIVERSITY Third HOSPITAL</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dou Hongliang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dai Hong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Chinese people's liberation army 474 hospital</name>
      <address>
        <city>Beijin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xiao Yun</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>XU Huizuo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University</name>
      <address>
        <city>Hainan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cheng Wangling</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hebei Eye Hospital</name>
      <address>
        <city>Hebei</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhang Minglian</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University</name>
      <address>
        <city>Hebei</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ma Jingxue</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Province People's Hospital</name>
      <address>
        <city>Henan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fan Ke</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Jilin University</name>
      <address>
        <city>Jilin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Su Guanfang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lanzhou University Second Hospital</name>
      <address>
        <city>Lanzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhang Wenfang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Eye Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yi Jinglin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhou Qiong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital With Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Liu Qinghuai</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Eye&amp;Ent Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhang Yongjin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Renji Hospital Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Liu Lin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai General Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yu Suqin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stu/Cuhk Joint Shantou International Eye Center</name>
      <address>
        <city>Shantou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cheng Weiqi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Eye Hospital</name>
      <address>
        <city>Shanxi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jia Yading</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shenzhen Eye Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cheng Qingshan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Eye Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Li Xiaorong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Eye Hospital of Wmu Zhejiang Eye Hospital</name>
      <address>
        <city>Wenzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Liu Xiaoling</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Renmin Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xing Yiqiao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiamen Eye Centre of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wu Guoji</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ningxia Peple'S Hospital</name>
      <address>
        <city>Yinchuan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ha Shaoping</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Zhejiang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yao ke</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03244657
org study id: KH902-STE-CRP-1.2
nct id: NCT03244657
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term
      treatment of polypoid choroidal vasculopathy (PCV) subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change of best corrected visual acuity (BCVA)
time frame: up to 40 week
description: 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;
measure: adverse events
time frame: up to 40 week
description: Assess incidence and severity of adverse events in subjects.
measure: mean of change of BCVA
time frame: up to 40 week
description: 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
measure: change of central retinal thickness (CRT)
time frame: up to 40 week
description: 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;
measure: mean of change of lesion's maximum retinal thickness (MRT)
time frame: up to 40 week
description: 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;
measure: average number of times of drug administration
time frame: up to 40 week
description: Assess average number of times of drug administration in two groups of subjects during the extension treatment;
arm group label: Q12W group
arm group type: Experimental
arm group label: TAE group
arm group type: Experimental
intervention type: Drug
intervention name: conbercept ophthalmic injection （0.5mg）
description: 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
arm group label: Q12W group
intervention type: Drug
intervention name: conbercept ophthalmic injection （0.5mg）
description: 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.
arm group label: TAE group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Li xiaoxing
phone: +86-13801153661
email: dr_lixiaoxin@163.com
facility: 
status: Not yet recruiting
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contact: 
country: China
responsible party type: Sponsor
mesh term: Vascular Diseases