<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2012120711647N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-03-20</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of bevacizumab on success of trabeculectomy in glaucoma patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of success of trabeculectomy in glaucoma patients treated with trabeculectomy alone versus adjunctive intracameral bevacizumab-combined trabeculectomy: A clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11822</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The reason for this study being double-blind is:&#13;
&#13;
The investigator (the surgeon who performs trabeculectomies) is blinded, because at the end of operation he takes a syringe containing 0.05 ml of a clear liquid, but he does not know what is the liquid (either bevacizumab or balanced salt solution). The two mentioned liquids have similar appearance. However, a nurse who prepares the syringe with 0.05 ml liquid is told to fill it with either bevacizumab or balanced salt solution, and this information is recorded but not provided to the surgeon who performs trabeculectomies and the physician who visits the patients in the follow up period.&#13;
&#13;
The patient is also blinded to what he/she receives. The informed consent states that they either receive placebo or the drug bevacizumab, which is chosen by random.</study_design>
      <phase>2</phase>
      <hc_freetext>Primary open-angle glaucoma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: single injection of 1.25 mg  (0.05 ml; concentration 25 mg/ml) bevacizumab (monoclonal antibody against VEGF; trade name Avastin, Genentech/Roche, San Francisco, CA) in the anterior chamber at termination of trabeculectomy surgery. Intervention 2: Intervention 2: single injection of placebo (0.05 ml balanced salt solution) in the anterior chamber at termination of trabeculectomy surgery.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Ghadimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5541 8112</telephone>
        <email>hadi.ghadimi@gmail.com</email>
        <affiliation>Farabi Eye Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghasem Fakhraie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farabi Eye Hospital, Qazvin Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5541 8112</telephone>
        <email>drfakhraee@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Primary open angle or pseudoexfoliative glaucoma patients 65 years or older who are candidates of standard trabeculectomy procedure (whose optic nerve function is failing or is likely to fail and is already on the maximum tolerated medical therapy and not likely to achieve a sufficient lOP reduction with laser treatment).&#13;
&#13;
Exclusion criteria: Patients at high risk of failure of trabeculectomy, including aphakic, pseudophakic, uveitic, neovascular and juvenile glaucoma.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>99 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Glaucoma (primary)(residual stage): capsular with pseudoexfoliation of lens, chronic simple, low-tension, pigmentary</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: single injection of 1.25 mg  (0.05 ml; concentration 25 mg/ml) bevacizumab (monoclonal antibody against VEGF; trade name Avastin, Genentech/Roche, San Francisco, CA) in the anterior chamber at termination of trabeculectomy surgery</i_keyword>
      <i_keyword>Intervention 2: single injection of placebo (0.05 ml balanced salt solution) in the anterior chamber at termination of trabeculectomy surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success of trabeculectomy. Timepoint: six months after surgery. Method of measurement: Goldmann applanation tonometry (intraocular pressure between 6 and 21 ml Hg and 30% reduction of intraocular pressure compared to preoperative values).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intraocular pressure. Timepoint: Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: Goldmann applanation tonometry.</sec_outcome>
      <sec_outcome>Corrected distance visual acuity. Timepoint: Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: clinical examination.</sec_outcome>
      <sec_outcome>Morphology of filtration Bleb. Timepoint: one day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: Slit lamp exam; Moorfields bleb grading system and Indiana bleb appearance grading scale.</sec_outcome>
      <sec_outcome>Number of medications used to lower the intraocular pressure. Timepoint: Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: History.</sec_outcome>
      <sec_outcome>Complications of intervention including bleb leak, encapsulation and need to globe massage. Timepoint: one day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: clinical examination.</sec_outcome>
      <sec_outcome>Visual field. Timepoint: Before and 6 months after surgery. Method of measurement: perimetry.</sec_outcome>
      <sec_outcome>Optic nerve head appearance and cup to disc ratio. Timepoint: Before and 6 months after surgery. Method of measurement: slit lamp exam and OCT of optic nerve head.</sec_outcome>
      <sec_outcome>Status of nerve fiber layer. Timepoint: Before and 6 months after surgery. Method of measurement: GDX and OCT of nerve fiber layer.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-13</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Qods St., Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
