<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/NCT01701518</url>
  </required_header>
  <id_info>
    <org_study_id>OZ123</org_study_id>
    <secondary_id>OZ123</secondary_id>
    <nct_id>NCT01701518</nct_id>
  </id_info>
  <brief_title>A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes</brief_title>
  <official_title>A Prospective Multicentre Pilot Study of the Effectiveness of an Intra-operative Intravitreal Sustained Release Dexamethasone Implant (Ozurdex®) in Vitrectomy Surgery for Epiretinal Membranes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected&#xD;
      at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for&#xD;
      idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as&#xD;
      demonstrated by a gain in vision and decreased in retinal thickness and volume.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We believe that the use of intravitreal corticosteroids post-operatively has the capacity to&#xD;
      mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy&#xD;
      for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone&#xD;
      implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal&#xD;
      membrane surgery. Its duration of action and its drug delivery characteristics over 6 months&#xD;
      approximately match the post-operative time course of healing and remodeling in an edematous&#xD;
      retina.&#xD;
&#xD;
      This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal&#xD;
      sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in&#xD;
      15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>3 Months</time_frame>
    <description>Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity at 1,4 and 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal thickness and volume</measure>
    <time_frame>6 months</time_frame>
    <description>Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure (IOP)</measure>
    <time_frame>6 months</time_frame>
    <description>Change of IOP from baseline will be monitored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cataract progression (if applicable)</measure>
    <time_frame>6 months</time_frame>
    <description>For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Epiretinal Membrane</condition>
  <condition>Macular Edema</condition>
  <arm_group>
    <arm_group_label>Ozurdex</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ozurdex</intervention_name>
    <description>biodegradable 0.7mg dexamethasone implant</description>
    <arm_group_label>Ozurdex</arm_group_label>
    <other_name>0.7mg dexamethasone implant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic&#xD;
             epiretinal membrane.&#xD;
&#xD;
          -  Central retinal thickness ≥ 250 μm.&#xD;
&#xD;
          -  Age more than 18 years old.&#xD;
&#xD;
          -  Decision makers able to give informed consent.&#xD;
&#xD;
          -  Females of child bearing potential must agree to use acceptable means of birth control&#xD;
             for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).&#xD;
&#xD;
          -  Any other macular pathology that could affect anatomic or functional results.&#xD;
&#xD;
          -  History of uveitis requiring intravitreal triamcinolone injection.&#xD;
&#xD;
          -  History of steroid-responsive glaucoma.&#xD;
&#xD;
          -  History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).&#xD;
&#xD;
          -  IOP &gt; 23 mm Hg if untreated, or &gt; 21 mm Hg if treated with medication.&#xD;
&#xD;
          -  Pregnant or breast-feeding woman.&#xD;
&#xD;
          -  Unable to attend the scheduled follow-up appointments.&#xD;
&#xD;
          -  Patients with known hypersensitivity to any components of Ozurdex® or to other&#xD;
             corticosteroids.&#xD;
&#xD;
          -  Patients with active or suspected ocular or periocular infections including most viral&#xD;
             diseases of the cornea and conjunctiva, including active epithelial herpes simplex&#xD;
             keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and&#xD;
             fungal diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter J Kertes, MD,CM,FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Charlene Muller</last_name>
    <phone>416-480-5091</phone>
    <email>charlene.muller@sunnybrook.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charlene Muller</last_name>
      <phone>416-480-5091</phone>
      <email>charlene.muller@sunnybrook.ca</email>
    </contact>
    <investigator>
      <last_name>Peter J Kertes, MD,CM,FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rajeev Muni, MD, FRCSC</last_name>
      <phone>(416) 867-7422</phone>
      <email>rajeev.muni@utoronto.ca</email>
    </contact>
    <investigator>
      <last_name>Rajeev Muni, MD,FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>January 4, 2016</last_update_submitted>
  <last_update_submitted_qc>January 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ozurdex</keyword>
  <keyword>Dexamethasone</keyword>
  <keyword>Epiretinal membrane</keyword>
  <keyword>Macular edema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Epiretinal Membrane</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>July 3, 2018</submitted>
    <returned>January 11, 2019</returned>
  </pending_results>
  <!-- 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/NCT01701518
org study id: OZ123
secondary id: OZ123
nct id: NCT01701518
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected
      at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for
      idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as
      demonstrated by a gain in vision and decreased in retinal thickness and volume.
We believe that the use of intravitreal corticosteroids post-operatively has the capacity to
      mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy
      for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone
      implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal
      membrane surgery. Its duration of action and its drug delivery characteristics over 6 months
      approximately match the post-operative time course of healing and remodeling in an edematous
      retina.

      This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal
      sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in
      15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Best corrected visual acuity
time frame: 3 Months
description: Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
measure: Best corrected visual acuity at 1,4 and 6 months
time frame: 6 months
description: Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
measure: Retinal thickness and volume
time frame: 6 months
description: Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).
measure: Intraocular pressure (IOP)
time frame: 6 months
description: Change of IOP from baseline will be monitored.
measure: Cataract progression (if applicable)
time frame: 6 months
description: For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.
arm group label: Ozurdex
arm group type: Other
description: Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane
intervention type: Drug
intervention name: Ozurdex
description: biodegradable 0.7mg dexamethasone implant
arm group label: Ozurdex
other name: 0.7mg dexamethasone implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter J Kertes, MD,CM,FRCSC
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
last name: Charlene Muller
phone: 416-480-5091
email: charlene.muller@sunnybrook.ca
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Epiretinal Membrane
mesh term: Dexamethasone
submitted: July 3, 2018
returned: January 11, 2019