<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/NCT03821168</url>
  </required_header>
  <id_info>
    <org_study_id>95287</org_study_id>
    <nct_id>NCT03821168</nct_id>
  </id_info>
  <brief_title>The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema</brief_title>
  <official_title>The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible&#xD;
      and progressive event that will not stop till reattachment of RPE and neurosensory retina&#xD;
      happened .&#xD;
&#xD;
      Process of degeneration begins from first hours of RD establishment Neuroprotection of&#xD;
      photoreceptor following RD is a novel and debatable discussion encountered in recent years .&#xD;
&#xD;
      How to stop this phenomena and neuroprotective agent role in this issue are a new interest of&#xD;
      researches.&#xD;
&#xD;
      In the study investigators are planning to perform a clinical trial to demonstrate the&#xD;
      minocycline neuroprotective effect in a double blind design as this impact has been&#xD;
      implicated previously in a animal study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>best corrected visual acuity</measure>
    <time_frame>1 month</time_frame>
    <description>Snellen chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography</measure>
    <time_frame>1 month</time_frame>
    <description>Optical coherence tomography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Refractory Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>intravitreal injection of bevacizumab and erythropoietin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>erythropoietin:</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intravitreal injection of bevacizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bevacizumab:1.25 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>injection of bevacizumab and erythropoietin</intervention_name>
    <description>injection of bevacizumab and erythropoietin</description>
    <arm_group_label>intravitreal injection of bevacizumab and erythropoietin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>injection of bevacizumab</intervention_name>
    <description>under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness</description>
    <arm_group_label>intravitreal injection of bevacizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with refractory diabetic macular edema at least one month after third&#xD;
             injection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous vitreoretinal surgery previous glaucoma surgery glaucomatous patient open&#xD;
             heart surgery active proliferative diabetic retinopathy one eye patients vitreous&#xD;
             hemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Morteza Entezari, MD</last_name>
    <phone>009822591616</phone>
    <email>labbafi@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ophthalmic Research Center</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Morteza Entzari, MD</last_name>
      <phone>009822591616</phone>
      <email>labbafi@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zahra Rabbani Khah</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Epoetin Alfa</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/NCT03821168
org study id: 95287
nct id: NCT03821168
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible
      and progressive event that will not stop till reattachment of RPE and neurosensory retina
      happened .

      Process of degeneration begins from first hours of RD establishment Neuroprotection of
      photoreceptor following RD is a novel and debatable discussion encountered in recent years .

      How to stop this phenomena and neuroprotective agent role in this issue are a new interest of
      researches.

      In the study investigators are planning to perform a clinical trial to demonstrate the
      minocycline neuroprotective effect in a double blind design as this impact has been
      implicated previously in a animal study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: best corrected visual acuity
time frame: 1 month
description: Snellen chart
measure: Optical coherence tomography
time frame: 1 month
description: Optical coherence tomography
arm group label: intravitreal injection of bevacizumab and erythropoietin
arm group type: Active Comparator
description: erythropoietin:
arm group label: intravitreal injection of bevacizumab
arm group type: Active Comparator
description: bevacizumab:1.25 mg
intervention type: Drug
intervention name: injection of bevacizumab and erythropoietin
description: injection of bevacizumab and erythropoietin
arm group label: intravitreal injection of bevacizumab and erythropoietin
intervention type: Drug
intervention name: injection of bevacizumab
description: under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness
arm group label: intravitreal injection of bevacizumab
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Morteza Entezari, MD
phone: 009822591616
email: labbafi@hotmail.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University of Medical Sciences
investigator full name: Zahra Rabbani Khah
investigator title: Clinical Professor
mesh term: Macular Edema
mesh term: Edema
mesh term: Bevacizumab
mesh term: Epoetin Alfa