<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/NCT01707745</url>
  </required_header>
  <id_info>
    <org_study_id>Avastin for threshold ROP.</org_study_id>
    <nct_id>NCT01707745</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sivakami A Pai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dubai Health Authority</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In&#xD;
      retinopathy of prematurity (ROP).&#xD;
&#xD;
      Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>N/A</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>Regression Of ROP</measure>
    <time_frame>Minimum 6 months follow up after intravitreal Avastin</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of ROP</measure>
    <time_frame>minimum 6 months of follow up.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.</condition>
  <arm_group>
    <arm_group_label>Avastin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Bevacizumab(Avastin) 0.75mg in 0.03 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intravitreal Bevacizumab</intervention_name>
    <arm_group_label>Avastin</arm_group_label>
    <other_name>Intravitreal Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: stage 2+ or stage 3+ Retinopathy of prematurity in Zone I or Zone II.&#xD;
&#xD;
        Informed written consent by parents or guardian.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Refusal to give consent Critically ill neonates.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>32 Weeks</minimum_age>
    <maximum_age>42 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sivakami A Pai, MS, DNB, Phd</last_name>
    <phone>00971504148256</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>M A Dekhain, FRCS, MRCOpth</last_name>
    <phone>0097142195000</phone>
    <phone_ext>6272</phone_ext>
    <email>maDekhain@dha.gov.ae</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dubai Hospital</name>
      <address>
        <city>Dubai</city>
        <state>UAE</state>
        <country>United Arab Emirates</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sivakami A Pai, MS, DNB, Phd</last_name>
      <phone>00971504148256</phone>
    </contact>
    <contact_backup>
      <last_name>Moza A Dekhain, MRCOpthal, FRCS</last_name>
      <phone>009712195000</phone>
      <phone_ext>6272</phone_ext>
      <email>maDekhain@dha.gov.ae</email>
    </contact_backup>
    <investigator>
      <last_name>Sivakami A Pai, MS, DNB, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Afra M Lootah, MSc, FRCS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dubai Health Authority</investigator_affiliation>
    <investigator_full_name>Sivakami A Pai</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinopathy of Prematurity</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/NCT01707745
org study id: Avastin for threshold ROP.
nct id: NCT01707745
lead sponsor: 
has dmc: Yes
Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In
      retinopathy of prematurity (ROP).

      Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Regression Of ROP
time frame: Minimum 6 months follow up after intravitreal Avastin
measure: Recurrence of ROP
time frame: minimum 6 months of follow up.
arm group label: Avastin
arm group type: Other
description: Bevacizumab(Avastin) 0.75mg in 0.03 ml
intervention type: Procedure
intervention name: Intravitreal Bevacizumab
arm group label: Avastin
other name: Intravitreal Avastin
criteria: 
gender: All
minimum age: 32 Weeks
maximum age: 42 Weeks
healthy volunteers: No
last name: Sivakami A Pai, MS, DNB, Phd
phone: 00971504148256
last name: M A Dekhain, FRCS, MRCOpth
phone: 0097142195000
phone ext: 6272
email: maDekhain@dha.gov.ae
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United Arab Emirates
responsible party type: Sponsor-Investigator
investigator affiliation: Dubai Health Authority
investigator full name: Sivakami A Pai
investigator title: Doctor
mesh term: Retinopathy of Prematurity
mesh term: Bevacizumab