<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/NCT01724385</url>
  </required_header>
  <id_info>
    <org_study_id>I55116</org_study_id>
    <nct_id>NCT01724385</nct_id>
  </id_info>
  <brief_title>Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy</brief_title>
  <official_title>Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation</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 the efficacy of intravitreal bevacizumab injections for treatment of&#xD;
      proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after&#xD;
      previous full panretinal photocoagulation (PRP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will carry out a prospective study in patients with PDR and prior complete&#xD;
      laser treatment who presented with new dense VH. All eyes will be treated with intravitreal&#xD;
      injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular&#xD;
      ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after&#xD;
      first injection. Re-injection will be done in non-clearing and recurrent VH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of eyes that vitreous hemorrhage has been completely resolved</measure>
    <time_frame>12 months</time_frame>
    <description>The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change in best corrected visual acuity (BCVA) from baseline</measure>
    <time_frame>12 months</time_frame>
    <description>The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Numbers of injection</measure>
    <time_frame>12 months</time_frame>
    <description>Numbers of intravitreous bevacizumab injection in a 12-month period</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Vitreous Hemorrhage</condition>
  <condition>Proliferative Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>intravitreal bevacizumab injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravitreal injection of bevacizumab 1.25 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intravitreal injection of bevacizumab</intervention_name>
    <description>intravitreal injection of bevacizumab</description>
    <arm_group_label>intravitreal bevacizumab injection</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with diabetes mellitus&#xD;
&#xD;
          -  proliferative diabetic retinopathy&#xD;
&#xD;
          -  prior complete panretinal photocoagulation&#xD;
&#xD;
          -  presented with new dense vitreous hemorrhage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  one-eyed patient&#xD;
&#xD;
          -  previous intraocular surgery&#xD;
&#xD;
          -  severe lens opacity precluding fundus examination&#xD;
&#xD;
          -  advance glaucoma&#xD;
&#xD;
          -  history of thromboembolic events such as myocardial infarction and cerebrovascular&#xD;
             accident&#xD;
&#xD;
          -  uncontrolled systemic hypertension, systolic blood pressure &gt; 180 mmHg or diastolic&#xD;
             blood pressure &gt; 110 mmHg&#xD;
&#xD;
          -  known coagulation abnormalities or current use of anticoagulant medications other than&#xD;
             aspirin&#xD;
&#xD;
          -  known allergies to any relevant drugs in this study&#xD;
&#xD;
          -  evidence of external ocular infection such as conjunctivitis and significant&#xD;
             blepharitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suthasinee Sinawat, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Ophthalmology, Faculty of Medicine, Khon Kaen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Srinagarind Hospital, Khon Kaen University</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>April 25, 2013</last_update_submitted>
  <last_update_submitted_qc>April 25, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 26, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Yosanan Yospaiboon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>bevacizumab,</keyword>
  <keyword>proliferative diabetic retinopathy,</keyword>
  <keyword>vitreous hemorrhage,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Vitreous Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
  </intervention_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/NCT01724385
org study id: I55116
nct id: NCT01724385
lead sponsor: 
has dmc: Yes
To evaluate the efficacy of intravitreal bevacizumab injections for treatment of
      proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after
      previous full panretinal photocoagulation (PRP).
The investigators will carry out a prospective study in patients with PDR and prior complete
      laser treatment who presented with new dense VH. All eyes will be treated with intravitreal
      injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular
      ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after
      first injection. Re-injection will be done in non-clearing and recurrent VH.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The percentage of eyes that vitreous hemorrhage has been completely resolved
time frame: 12 months
description: The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.
measure: The change in best corrected visual acuity (BCVA) from baseline
time frame: 12 months
description: The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.
measure: Numbers of injection
time frame: 12 months
description: Numbers of intravitreous bevacizumab injection in a 12-month period
arm group label: intravitreal bevacizumab injection
arm group type: Experimental
description: intravitreal injection of bevacizumab 1.25 mg
intervention type: Drug
intervention name: intravitreal injection of bevacizumab
description: intravitreal injection of bevacizumab
arm group label: intravitreal bevacizumab injection
other name: Avastin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Suthasinee Sinawat, M.D.
role: Principal Investigator
affiliation: Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Yosanan Yospaiboon
investigator title: Professor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Vitreous Hemorrhage
mesh term: Hemorrhage
mesh term: Bevacizumab