<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/NCT01686529</url>
  </required_header>
  <id_info>
    <org_study_id>CC-008-2010</org_study_id>
    <nct_id>NCT01686529</nct_id>
  </id_info>
  <brief_title>Bevacizumab for Primary Pterygium Treatment</brief_title>
  <official_title>Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Oftalmología Fundación Conde de Valenciana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Oftalmología Fundación Conde de Valenciana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the efficacy and safety of subconjunctival&#xD;
      bevacizumab application as an adjuvant therapy for primary pterygium.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2011</primary_completion_date>
  <phase>Phase 1</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pterygium recurrence</measure>
    <time_frame>One point.</time_frame>
    <description>The pterygium recurrence is evaluated at one year postoperative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conjunctival ischemia</measure>
    <time_frame>Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative</time_frame>
    <description>Whiteness of conjunctival bed, that means absence of blood vessels</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Pterygium</condition>
  <arm_group>
    <arm_group_label>One subconjunctival injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two subconjuctival injections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Autoconjunctival grafting without subconjuntival bevacizumab injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autoconjunctival grafting</intervention_name>
    <description>The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.</description>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_label>One subconjunctival injection</arm_group_label>
    <arm_group_label>Two subconjuctival injections</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subconjuntival bevacizumab injection</intervention_name>
    <description>The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.</description>
    <arm_group_label>One subconjunctival injection</arm_group_label>
    <arm_group_label>Two subconjuctival injections</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with primary pterygium&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with diabetes mellitus&#xD;
&#xD;
          -  collagenopathies,&#xD;
&#xD;
          -  previous ocular surgeries,&#xD;
&#xD;
          -  pregnant or lactating patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yonathan Garfias, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto de Oftalmología</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Oftalmología</name>
      <address>
        <city>Mexico City</city>
        <zip>06800</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/23777441</url>
    <description>This is the link to the reference published on Pubmed</description>
  </link>
  <results_reference>
    <citation>Nava-Castaneda A, Olvera-Morales O, Ramos-Castellon C, Garnica-Hayashi L, Garfias Y. Randomized, controlled trial of conjunctival autografting combined with subconjunctival bevacizumab for primary pterygium treatment: 1-year follow-up. Clin Exp Ophthalmol. 2014 Apr;42(3):235-41. doi: 10.1111/ceo.12140. Epub 2013 Jul 5.</citation>
    <PMID>23777441</PMID>
  </results_reference>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>December 5, 2013</last_update_submitted>
  <last_update_submitted_qc>December 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pterygium</keyword>
  <keyword>bevacizumab</keyword>
  <keyword>autoconjunctival graft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pterygium</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/NCT01686529
org study id: CC-008-2010
nct id: NCT01686529
lead sponsor: 
has dmc: No
The aim of this study was to investigate the efficacy and safety of subconjunctival
      bevacizumab application as an adjuvant therapy for primary pterygium.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Pterygium recurrence
time frame: One point.
description: The pterygium recurrence is evaluated at one year postoperative
measure: Conjunctival ischemia
time frame: Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative
description: Whiteness of conjunctival bed, that means absence of blood vessels
arm group label: One subconjunctival injection
arm group type: Experimental
description: Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery
arm group label: Two subconjuctival injections
arm group type: Experimental
description: Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery
arm group label: Conventional treatment
arm group type: Active Comparator
description: Autoconjunctival grafting without subconjuntival bevacizumab injection
intervention type: Procedure
intervention name: Autoconjunctival grafting
description: The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.
arm group label: Conventional treatment
arm group label: One subconjunctival injection
arm group label: Two subconjuctival injections
intervention type: Drug
intervention name: Subconjuntival bevacizumab injection
description: The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.
arm group label: One subconjunctival injection
arm group label: Two subconjuctival injections
other name: Avastin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yonathan Garfias, MD, PhD
role: Principal Investigator
affiliation: Instituto de Oftalmología
facility: 
country: Mexico
url: http://www.ncbi.nlm.nih.gov/pubmed/23777441
description: This is the link to the reference published on Pubmed
citation: Nava-Castaneda A, Olvera-Morales O, Ramos-Castellon C, Garnica-Hayashi L, Garfias Y. Randomized, controlled trial of conjunctival autografting combined with subconjunctival bevacizumab for primary pterygium treatment: 1-year follow-up. Clin Exp Ophthalmol. 2014 Apr;42(3):235-41. doi: 10.1111/ceo.12140. Epub 2013 Jul 5.
PMID: 23777441
responsible party type: Sponsor
mesh term: Pterygium
mesh term: Bevacizumab