<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/NCT01726790</url>
  </required_header>
  <id_info>
    <org_study_id>HE541020</org_study_id>
    <nct_id>NCT01726790</nct_id>
  </id_info>
  <brief_title>Effect of Intravitreal Bevacizumab on Corneal Endothelium</brief_title>
  <official_title>Effect of Intravitreal Bevacizumab on Corneal Endothelium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khon Kaen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravitreal Bevacizumab has been used by retinal specialist in treatment many retinal&#xD;
      diseases. Although it not approved by FDA for treatment. In many In vitro studies, its showed&#xD;
      saftey in the eyes especially for corneal endothelium cells, that important cells to keep&#xD;
      cornea clear. This study use Confoscan-Corneal confocal microsope to evaluate corneal&#xD;
      endothelium before and after intravitreal Bevacizumab injection in routine retinal disease at&#xD;
      6 month follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal endothelium cell change after intravitreal Bevacizumab injection</measure>
    <time_frame>6 months</time_frame>
    <description>Measure the corneal endothelium cell using Confoscan4-Corneal confocal microscope in patient in retinal vascular clinic before and after treat with intravitreal Bevacizumab</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the complication after intravitreal Bevacizumab injection</measure>
    <time_frame>6 month</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Corneal Endothelial Cell Loss</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient in retinalvascular clinic with diagnosis of retinal vein occlusion with macular&#xD;
        edema, diabetic macular edema, wet aged related macular degeneration and submacular&#xD;
        hemorrhage)treated with intravitreal Bevacizumab&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 20 and 80 years old&#xD;
&#xD;
          -  can come to regular follow up at 6 month&#xD;
&#xD;
          -  signed written consent forms&#xD;
&#xD;
          -  not have corneal scar, or glaucoma&#xD;
&#xD;
          -  history of treatment with laser or anti-VEGF therapy in 3 month prior to recruit&#xD;
&#xD;
          -  high risk in cerebrovascular and cardiovascular diseases&#xD;
&#xD;
          -  Pregnancy and breastfeeding&#xD;
&#xD;
          -  can undergo confocal microspopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of intraocular surgery or ocular trauma during study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kasem Yospaiboon, MD</last_name>
    <phone>66823057231</phone>
    <email>kasem_yod@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>KKU eye center, department of Ophthalmolgy, faculty of medicine, khon kaen university</name>
      <address>
        <city>Khon kaen</city>
        <zip>4002</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yosanan Yospaiboon, Professor</last_name>
      <phone>6643363010</phone>
      <email>yosanan@kku.ac.th</email>
    </contact>
    <investigator>
      <last_name>Kasem Yospaiboon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 11, 2012</study_first_submitted>
  <study_first_submitted_qc>November 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 11, 2012</last_update_submitted>
  <last_update_submitted_qc>November 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Kasem Yospaiboon</investigator_full_name>
    <investigator_title>Kasem Yospaiboon, MD</investigator_title>
  </responsible_party>
  <keyword>corneal endothelium</keyword>
  <keyword>Bevacizumab</keyword>
  <keyword>Intravitreal injection</keyword>
  <keyword>Confoscan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Corneal Endothelial Cell Loss</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/NCT01726790
org study id: HE541020
nct id: NCT01726790
lead sponsor: 
has dmc: Yes
To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection
Intravitreal Bevacizumab has been used by retinal specialist in treatment many retinal
      diseases. Although it not approved by FDA for treatment. In many In vitro studies, its showed
      saftey in the eyes especially for corneal endothelium cells, that important cells to keep
      cornea clear. This study use Confoscan-Corneal confocal microsope to evaluate corneal
      endothelium before and after intravitreal Bevacizumab injection in routine retinal disease at
      6 month follow up.
observational model: Case-Only
time perspective: Prospective
measure: Corneal endothelium cell change after intravitreal Bevacizumab injection
time frame: 6 months
description: Measure the corneal endothelium cell using Confoscan4-Corneal confocal microscope in patient in retinal vascular clinic before and after treat with intravitreal Bevacizumab
measure: Assess the complication after intravitreal Bevacizumab injection
time frame: 6 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kasem Yospaiboon, MD
phone: 66823057231
email: kasem_yod@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Kasem Yospaiboon
investigator title: Kasem Yospaiboon, MD
mesh term: Corneal Endothelial Cell Loss