<?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>IRCT2014101618966N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-10-23</date_registration>
      <primary_sponsor>No sponsor</primary_sponsor>
      <public_title>The treatment of retinopathy of prematurity with Avastin</public_title>
      <acronym></acronym>
      <scientific_title>The Prevention of Blindness in Retinopathy of Prematurity by Intravitreal Injection of Bevacizumab</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17073</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Retinopathy of prematurity.</hc_freetext>
      <i_freetext>A dose of bevacizumab of 0.625 mg in 0.025 ml was injected in each eye from the study sample, according to the following protocol: The pupils were dilated with a mixture of tropicamide 0.5% and phenylephrine 0.5%. Anesthesia was achieved with 0.5% proparacaine hydrochloride administered topically, 3 times, every 2 minutes before the injection. Every eye was prepared in a sterile manner using 5% povidone iodine which was also instilled in the eye 3 minutes prior the injection. A nurse hold the infant's head during the procedure and 0.025 ml of bevacizumab (0.625 mg) were injected in pars plicata, 1.5 - 1.75 mm away from the limbus, with a 30 G needle, perpendicularly on the globe initially and then slightly directed toward the center of the eyeball. After the injection, the patients received topical tobramycin, 5 times/day, for 3 days. The patients were re-examined the next day and then every week to monitor the regression of the disease. The follow-up continued for 52 weeks, every 1 or 2 weeks until full vascularization of the retina was observed. Full vascularization was defined as follows: vascularization as far as it would develop without an active component or clinically significant tractional elements. All the treatments were carried out by the same physician and the examinations were performed by three ophthalmologists experienced in ROP..</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>Nicoara Simona Delia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8, V. Babes str.</address>
        <city>Cluj-Napoca</city>
        <country1>Romania</country1>
        <zip></zip>
        <telephone>0040264597256</telephone>
        <email>simonanicoara1@gmail.com</email>
        <affiliation>"Iuliu Hatieganu" University of Medicine and Pharmacy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Cristian Cristina</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8, V. Babes str.</address>
        <city>Cluj-Napoca</city>
        <country1>Romania</country1>
        <zip></zip>
        <telephone>0040264597256</telephone>
        <email>christinacristian@gmail.com</email>
        <affiliation>"Iuliu Hatieganu" University of Medicine and Pharmacy</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Romania</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: all the premature new borns that received intravitreal bevacizumab injections for retinopathy of prematurity</inclusion_criteria>
      <agemin>20 days</agemin>
      <agemax>3 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H35.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Retinopathy of prematurity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A dose of bevacizumab of 0.625 mg in 0.025 ml was injected in each eye from the study sample, according to the following protocol: The pupils were dilated with a mixture of tropicamide 0.5% and phenylephrine 0.5%. Anesthesia was achieved with 0.5% proparacaine hydrochloride administered topically, 3 times, every 2 minutes before the injection. Every eye was prepared in a sterile manner using 5% povidone iodine which was also instilled in the eye 3 minutes prior the injection. A nurse hold the infant's head during the procedure and 0.025 ml of bevacizumab (0.625 mg) were injected in pars plicata, 1.5 - 1.75 mm away from the limbus, with a 30 G needle, perpendicularly on the globe initially and then slightly directed toward the center of the eyeball. After the injection, the patients received topical tobramycin, 5 times/day, for 3 days. The patients were re-examined the next day and then every week to monitor the regression of the disease. The follow-up continued for 52 weeks, every 1 or 2 weeks until full vascularization of the retina was observed. Full vascularization was defined as follows: vascularization as far as it would develop without an active component or clinically significant tractional elements. All the treatments were carried out by the same physician and the examinations were performed by three ophthalmologists experienced in ROP.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Regression of retinopathy of prematurity. Timepoint: one week after the intravitreal injection of bevacizumab. Method of measurement: indirect ophthalmoscopy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Condition of the retina. Timepoint: 52 weeks after the intravitreal injection of bevacizumab weeks. Method of measurement: indirect ophthalmocsopy.</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>No sponsor</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-12-12</approval_date>
        <contact_name>Ethics Committee of the "Iuliu Hatieganu" University of Medicine and Pharmacy</contact_name>
        <contact_address>8, V. Babes str. Cluj-Napoca Cluj Romania</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
