<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/NCT02194634</url>
  </required_header>
  <id_info>
    <org_study_id>KHSWKH902010</org_study_id>
    <nct_id>NCT02194634</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)</brief_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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess safety and efficacy of intravitreal injection of Conbercept&#xD;
      on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from baseline in best corrected visual acuity (BCVA) at month 12</measure>
    <time_frame>Baseline and month 12</time_frame>
    <description>To compare mean change from baseline BCVA between treatment group and controlled group at month 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in central retinal thickness (CRT) between two groups</measure>
    <time_frame>Baseline and month 12</time_frame>
    <description>To compare mean change from baseline CRT between two groups at month 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection</measure>
    <time_frame>12 months</time_frame>
    <description>To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean changes from baseline of photographic parameters, such as CRT, total macular volume and leakage area etc.</measure>
    <time_frame>Baseline and every month, up to 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mean change from baseline BCVA between treatment group and controlled group</measure>
    <time_frame>Baseline and every month, up to 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in visual acuity distribution of treatment group and controlled group</measure>
    <time_frame>Month 6, month 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The 25-item National Eye Institute Visual Function Questionnaire （NEI VFQ-25）total score mean change from baseline of between treatment group and controlled group</measure>
    <time_frame>Month 6, month 12</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">248</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Conbercept treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conbercept injection and sham laser treatment at day 0 for 1st time, the investigators will decide whether the subjects need to get repeated treatment according to monthly assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laser treatment and sham injection at day 0 for 1st time, the investigators will decide whether the repeated laser treatment is needed according to monthly results during the visit after 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conbercept</intervention_name>
    <description>Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.</description>
    <arm_group_label>Conbercept treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham injection</intervention_name>
    <description>Sham intravitreal injection at first month, then repeated as needed.</description>
    <arm_group_label>Laser treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser</intervention_name>
    <description>Laser treatment at first month, then repeated as needed.</description>
    <arm_group_label>Laser treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham laser</intervention_name>
    <description>Sham laser at first month, then repeated as needed.</description>
    <arm_group_label>Conbercept treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients sign informed consent, and are willing and able to comply with all the&#xD;
             follow-ups;&#xD;
&#xD;
          2. Age ≥ 18 years , both genders;&#xD;
&#xD;
          3. Diagnosis of type 1 or type 2 diabetes mellitus;&#xD;
&#xD;
          4. Serum HbA1c ≤ 10%;&#xD;
&#xD;
          5. Study eye must meet the following criteria:&#xD;
&#xD;
               -  Visual acuity impairment caused by DME with involving foveal;&#xD;
&#xD;
               -  BCVA score ≥ 24 and ≤ 73 Early Treatment Diabetic Retinopathy Study (ETDRS)&#xD;
                  letters at 4 meter/1 meter of ETDRS test(Equivalent Snellen chart 20/40 to&#xD;
                  20/320);&#xD;
&#xD;
               -  Visual impairment due to Choroidal Neovascularization (CNV) secondary to high&#xD;
                  myopia.&#xD;
&#xD;
               -  Central retinal thickness (CRT) ≥300μm (spectral domain Optical Coherence&#xD;
                  Tomography (OCT), the CRT measurements must be confirmed by central reading&#xD;
                  center);&#xD;
&#xD;
               -  Refractive media opacities and miosis have no effect on the fundus examination.&#xD;
&#xD;
          6. Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active infectious ocular inflammation in either eye;&#xD;
&#xD;
          2. Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of&#xD;
             inactive, regressed PDR;&#xD;
&#xD;
          3. Any other ocular disorder in the study eye that may cause macular edema excluded the&#xD;
             diabetic retinopathy;&#xD;
&#xD;
          4. Iris neovascularization in the study eye;&#xD;
&#xD;
          5. Uncontrolled glaucoma, or history of glaucoma surgery;&#xD;
&#xD;
          6. Aphakia in the study eye;&#xD;
&#xD;
          7. History of vitrectomy in the study eye;&#xD;
&#xD;
          8. History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to&#xD;
             the screening, or possibly need panretinal photocoagulation of the study eye during&#xD;
             the study;&#xD;
&#xD;
          9. Liver, kidney dysfunction;&#xD;
&#xD;
         10. History of allergic reaction to fluorescein, protein agents for diagnosis or therapy,&#xD;
             or more than 2 drug or nondrug factors, or concomitant allergic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xun Xu, professor</last_name>
    <phone>86-21-63240090</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100083</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yuling Liu, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Tongren hospital affiliated to Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Feng Zhang, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Shaojun Chen, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Daping Hospital, Research Institute of Surgery Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jian Ye, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center , Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Xiao ling Liang, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eye hospital of Henan province</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ke Fan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wuhan General Hospital of Guangzhou Military</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430070</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yanping Song, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wuxi No.2 People's Hospital</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <zip>214002</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zhifeng Wu, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>He eye hospital</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Wei He, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai First People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Xun Xu, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kun Liu, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Renji hospital shanghai jiaotong university school of medcine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lin Liu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xian</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yusheng Wang, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Junjun Zhang, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eye center of Tianjin mendical university</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300070</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zhi qing Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Affiliated Eye Hospital of WMC</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Xiaoling Liu, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Bei jing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Junjie Ye, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>January 5, 2016</last_update_submitted>
  <last_update_submitted_qc>January 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2016</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>Macular Edema</mesh_term>
    <mesh_term>Edema</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/NCT02194634
org study id: KHSWKH902010
nct id: NCT02194634
lead sponsor: 
has dmc: No
This study is designed to assess safety and efficacy of intravitreal injection of Conbercept
      on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change from baseline in best corrected visual acuity (BCVA) at month 12
time frame: Baseline and month 12
description: To compare mean change from baseline BCVA between treatment group and controlled group at month 12.
measure: Mean change from baseline in central retinal thickness (CRT) between two groups
time frame: Baseline and month 12
description: To compare mean change from baseline CRT between two groups at month 12.
measure: Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection
time frame: 12 months
description: To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc.
measure: Mean changes from baseline of photographic parameters, such as CRT, total macular volume and leakage area etc.
time frame: Baseline and every month, up to 12 months
measure: Mean change from baseline BCVA between treatment group and controlled group
time frame: Baseline and every month, up to 12 months
measure: Change from baseline in visual acuity distribution of treatment group and controlled group
time frame: Month 6, month 12
measure: The 25-item National Eye Institute Visual Function Questionnaire （NEI VFQ-25）total score mean change from baseline of between treatment group and controlled group
time frame: Month 6, month 12
arm group label: Conbercept treatment group
arm group type: Experimental
description: Conbercept injection and sham laser treatment at day 0 for 1st time, the investigators will decide whether the subjects need to get repeated treatment according to monthly assessment.
arm group label: Laser treatment group
arm group type: Active Comparator
description: Laser treatment and sham injection at day 0 for 1st time, the investigators will decide whether the repeated laser treatment is needed according to monthly results during the visit after 3 months.
intervention type: Drug
intervention name: Conbercept
description: Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
arm group label: Conbercept treatment group
intervention type: Other
intervention name: Sham injection
description: Sham intravitreal injection at first month, then repeated as needed.
arm group label: Laser treatment group
intervention type: Procedure
intervention name: Laser
description: Laser treatment at first month, then repeated as needed.
arm group label: Laser treatment group
intervention type: Other
intervention name: Sham laser
description: Sham laser at first month, then repeated as needed.
arm group label: Conbercept treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xun Xu, professor
phone: 86-21-63240090
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: China
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema