<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/NCT04469777</url>
  </required_header>
  <id_info>
    <org_study_id>0304649</org_study_id>
    <nct_id>NCT04469777</nct_id>
  </id_info>
  <brief_title>Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy</brief_title>
  <official_title>Evaluation of the Effect of Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the&#xD;
      management of late stage optic neuropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Injury of the optic nerve or optic neuropathy is one of the most common causes of vision&#xD;
      loss. This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin&#xD;
      in the management of late stage optic neuropathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>The study included 20 patients diagnosed as late onset optic neuropathy that are attending Alexandria main university hospital.&#xD;
All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of visual acuity</measure>
    <time_frame>3 months</time_frame>
    <description>Visual acuity using appropriate charts for assessment then convert into log of the minimum angle of resolution (logMAR) units to provide a numeric scale of visual acuity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flash visual-evoked potentials</measure>
    <time_frame>3 months</time_frame>
    <description>Flash VEP to detect amplitude reduction and latency in the optic nerve.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Optic Neuropathy</condition>
  <arm_group>
    <arm_group_label>Systemic erythropoietin injections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients diagnosed as late onset optic neuropathy that were attending Alexandria main university hospital.Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>erythropoietin</intervention_name>
    <description>Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).</description>
    <arm_group_label>Systemic erythropoietin injections</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with late stage optic neuropathy (1 month to 12 months after onset of optic&#xD;
             neuropathy due to late referral of the cases)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with perforating ocular injuries were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mai ElBahwash, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>March 27, 2021</last_update_submitted>
  <last_update_submitted_qc>March 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Mohamed Fahmy Doheim</investigator_full_name>
    <investigator_title>Prinicipal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Optic Nerve Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04469777
org study id: 0304649
nct id: NCT04469777
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the
      management of late stage optic neuropathy.
Injury of the optic nerve or optic neuropathy is one of the most common causes of vision
      loss. This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin
      in the management of late stage optic neuropathy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study included 20 patients diagnosed as late onset optic neuropathy that are attending Alexandria main university hospital.
All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of visual acuity
time frame: 3 months
description: Visual acuity using appropriate charts for assessment then convert into log of the minimum angle of resolution (logMAR) units to provide a numeric scale of visual acuity
measure: Flash visual-evoked potentials
time frame: 3 months
description: Flash VEP to detect amplitude reduction and latency in the optic nerve.
arm group label: Systemic erythropoietin injections
arm group type: Experimental
description: 20 patients diagnosed as late onset optic neuropathy that were attending Alexandria main university hospital.Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
intervention type: Drug
intervention name: erythropoietin
description: Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
arm group label: Systemic erythropoietin injections
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mai ElBahwash, PhD
role: Principal Investigator
affiliation: Alexandria Faculty of Medicine
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Mohamed Fahmy Doheim
investigator title: Prinicipal investigator
mesh term: Optic Nerve Diseases
mesh term: Epoetin Alfa
sharing ipd: No