<?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>IRCT20170303032845N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-03</date_registration>
      <primary_sponsor>Aracell zist daru</primary_sponsor>
      <public_title>The Comparison of Efficacy Between Iranian Made Ranibizumab and Imported Ranibizumab in Diabetic Patients with Macular Edema</public_title>
      <acronym>SVLD</acronym>
      <scientific_title>The Comparison of the Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis®) with Imported Ranibizumab (Lucentis®) in Patients with Diabetic Macular Edema: A phase III, Two-armed, Double-blind, Parallel, Active-controlled, and Noninferiority Clinical Randomized Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>154</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35718</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block randomization
Unit of Randomization: Individual 
Randomization tool: web-based software
https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Both Ranibizumab drugs are indistinguishable for patients and the medical staff, and the only informed person is the nurse who is responsible for preparing the Ranibizumab according to the physician's instructions. Since Ranibizumab route of administration is intravitreal injection, it is possible to blind patients to the treatment groups. Additionally, people who evaluate the results and analyze data are not aware of the patients' group assignments.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabetic retinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru). Intervention 2: Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sayyed Amirpooya Alemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Eye Research Center, Rassoul Akram Hospital, Sattarkhan-Niayesh St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6655 8811</telephone>
        <email>s.amirpooya.alemzadeh@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Modarreszadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Eye Research Center, Rassoul Akram Hospital, Sattarkhan-Niayesh St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6655 8811</telephone>
        <email>mmodarres51@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetes mellitus type 1 or 2
Center involving macular edema with a central subfield thickness (CST) of &gt;300
Early treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400)
HbA1c&lt;9%
Blood Pressure &lt;150/100
Triglyceride and LDL up to 20% higher than upper normal limits
Pseudophakic patients are allowed to enter the study.
Signed written inform consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of intravitreal injection within the past 2 months
History of any ocular surgery within the past 6 months
History of glaucoma or ocular hypertension
Any media opacity in the cornea, lens and vitreous body which interferes with eye examination and imaging.
Monocular patients
Pregnant or breastfeeding women
Proliferative diabetic retinopathy (PDR) with high-risk characteristics
HbA1c&gt;10%
Smoking (more than 10 cigarettes per day)
Use of acetazolamide tablets or intraocular pressure-lowering drops
Use of systemic corticosteroids or nonsteroidal anti-inflammatory eye drops (NSAIDs)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus with ophthalmic complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru)</i_keyword>
      <i_keyword>Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Central macular thickness. Timepoint: At the beginning of the study (before the intervention), 30 days after injection. Method of measurement: Optical coherence tomography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Visual acuity. Timepoint: At the beginning of the study (before the intervention), 7 and 30  days after injection. Method of measurement: Snellen chart.</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>Aracell zist daru</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-08</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway. تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-29</approval_date>
        <contact_name>Farabi Eye Hospital- Tehran University of Medical Sciences</contact_name>
        <contact_address>The south Kargar St, Qazvin Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
