<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/NCT02995746</url>
  </required_header>
  <id_info>
    <org_study_id>15-475</org_study_id>
    <nct_id>NCT02995746</nct_id>
  </id_info>
  <brief_title>Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane</brief_title>
  <acronym>DEMO</acronym>
  <official_title>Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mid Atlantic Retina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wills Eye</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on&#xD;
      central macular thickness and visual acuity in those patients with persistent macular edema&#xD;
      after pars plana vitrectomy for epiretinal membrane.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Macular edema is a relatively common occurrence after pars plana vitrectomy. Kim et al&#xD;
      described that 47% of eyes undergoing vitrectomy for epiretinal membrane, macular hole, or&#xD;
      vitreous hemorrhage had evidence of macular thickening on optical coherence tomography scan.1&#xD;
      Post-vitrectomy macular edema can limit potential visual acuity gain from removal of a&#xD;
      symptomatic epiretinal membrane. Typical treatment of post-operative macular edema consists&#xD;
      of topical non-steroidal anti-inflammatory drugs (NSAIDs) and topical corticosteroids;&#xD;
      however, there are still resistant cases with refractory macular thickening.&#xD;
&#xD;
      The dexamethasone intravitreal implant (Ozurdex; Allergan, Irvine, CA) is currently&#xD;
      FDA-approved for the treatment of posterior uveitis as well as macular edema secondary to&#xD;
      retinal vein occlusion and diabetic retinopathy. Furino et al reported a retrospective series&#xD;
      describing how a single injection of the 0.7mg dexamethasone intravitreal implant resulted in&#xD;
      a substantial increase in best-corrected visual acuity (BCVA) and a decrease in central&#xD;
      macular thickness (CMT) on spectral-domain optical coherence tomography (SD-OCT) in 8&#xD;
      patients with persistent macular thickening after pars plana vitrectomy for epiretinal&#xD;
      membrane. There has been no prospective study evaluating the efficacy of this pharmacologic&#xD;
      agent in this setting.&#xD;
&#xD;
      As such, the purpose of this study is to prospectively evaluate the effect of the&#xD;
      intravitreal 0.7mg dexamethasone implant on CMT and BCVA in those patients with persistent&#xD;
      macular edema after pars plana vitrectomy for epiretinal membrane.&#xD;
&#xD;
      The results of this study will help delineate whether the intravitreal dexamethasone implant&#xD;
      has efficacy in improving CMT and/or visual acuity in those patients with refractory macular&#xD;
      thickening after pars plana vitrectomy for epiretinal membrane.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated due to lack of drug efficacy. 2017 study did not show benefit.&#xD;
  </why_stopped>
  <start_date type="Actual">January 28, 2016</start_date>
  <completion_date type="Actual">September 14, 2017</completion_date>
  <primary_completion_date type="Actual">September 14, 2017</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>Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant</measure>
    <time_frame>Change in mean macular thickness baseline at 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>Change in visual acuity baseline at 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Macular Edema</condition>
  <condition>Epiretinal Membrane</condition>
  <condition>Vitrectomy</condition>
  <arm_group>
    <arm_group_label>0.7mg dexamethasone intravitreal implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravitreal implantation of 0.7mg dexamethasone with a six month follow up period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>On study visit #1 all patients will have a SD-OCT scan and measurement of baseline visual acuity. All patients will receive the 0.7mg dexamethasone intravitreal implant&#xD;
Subsequent follow-up visits will be at 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months after intravitreal injection of dexamethasone implant&#xD;
Each visit will consist of measurement of visual acuity, intraocular pressure, dilated fundoscopic examination, and SD-OCT scan&#xD;
Anticipated duration of the study: 6 months</description>
    <arm_group_label>0.7mg dexamethasone intravitreal implant</arm_group_label>
    <other_name>Ozurdex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina&#xD;
             offices&#xD;
&#xD;
          2. Volunteer patients age 18 years and older&#xD;
&#xD;
          3. Healthy enough to participate in the study&#xD;
&#xD;
          4. Willing and able to consent to participation in the study&#xD;
&#xD;
          5. History of pars plan vitrectomy for symptomatic epiretinal membrane at least 3 months&#xD;
             prior to study enrollment date&#xD;
&#xD;
          6. BCVA of 20/40 or worse&#xD;
&#xD;
          7. CMT of at least 400 micrometers with or without cystoid macular edema on SD-OCT&#xD;
&#xD;
          8. Prior treatment with topical NSAIDs without resolution of macular thickening or visual&#xD;
             acuity improvement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Advanced glaucoma (cup-disc ratio of 0.8 or greater)&#xD;
&#xD;
          2. History of glaucoma filtering or tube shunt implant surgery&#xD;
&#xD;
          3. Steroid responsive intraocular hypertension&#xD;
&#xD;
          4. Diabetic retinopathy&#xD;
&#xD;
          5. History of uveitis&#xD;
&#xD;
          6. Use of systemic or intraocular corticosteroids&#xD;
&#xD;
          7. Active or suspected ocular or periocular infections&#xD;
&#xD;
          8. Other confounding intraocular pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allen C Ho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mid Atlantic Retina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mid Atlantic Retina</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wills Eye</investigator_affiliation>
    <investigator_full_name>Allen C. Ho, MD</investigator_full_name>
    <investigator_title>MD</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>Epiretinal Membrane</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 15, 2019</submitted>
    <returned>February 6, 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/NCT02995746
org study id: 15-475
nct id: NCT02995746
lead sponsor: 
collaborator: 
has dmc: No
This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on
      central macular thickness and visual acuity in those patients with persistent macular edema
      after pars plana vitrectomy for epiretinal membrane.
Macular edema is a relatively common occurrence after pars plana vitrectomy. Kim et al
      described that 47% of eyes undergoing vitrectomy for epiretinal membrane, macular hole, or
      vitreous hemorrhage had evidence of macular thickening on optical coherence tomography scan.1
      Post-vitrectomy macular edema can limit potential visual acuity gain from removal of a
      symptomatic epiretinal membrane. Typical treatment of post-operative macular edema consists
      of topical non-steroidal anti-inflammatory drugs (NSAIDs) and topical corticosteroids;
      however, there are still resistant cases with refractory macular thickening.

      The dexamethasone intravitreal implant (Ozurdex; Allergan, Irvine, CA) is currently
      FDA-approved for the treatment of posterior uveitis as well as macular edema secondary to
      retinal vein occlusion and diabetic retinopathy. Furino et al reported a retrospective series
      describing how a single injection of the 0.7mg dexamethasone intravitreal implant resulted in
      a substantial increase in best-corrected visual acuity (BCVA) and a decrease in central
      macular thickness (CMT) on spectral-domain optical coherence tomography (SD-OCT) in 8
      patients with persistent macular thickening after pars plana vitrectomy for epiretinal
      membrane. There has been no prospective study evaluating the efficacy of this pharmacologic
      agent in this setting.

      As such, the purpose of this study is to prospectively evaluate the effect of the
      intravitreal 0.7mg dexamethasone implant on CMT and BCVA in those patients with persistent
      macular edema after pars plana vitrectomy for epiretinal membrane.

      The results of this study will help delineate whether the intravitreal dexamethasone implant
      has efficacy in improving CMT and/or visual acuity in those patients with refractory macular
      thickening after pars plana vitrectomy for epiretinal membrane.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant
time frame: Change in mean macular thickness baseline at 6 months
measure: Visual acuity
time frame: Change in visual acuity baseline at 6 months
arm group label: 0.7mg dexamethasone intravitreal implant
arm group type: Experimental
description: Single intravitreal implantation of 0.7mg dexamethasone with a six month follow up period
intervention type: Drug
intervention name: Dexamethasone
description: On study visit #1 all patients will have a SD-OCT scan and measurement of baseline visual acuity. All patients will receive the 0.7mg dexamethasone intravitreal implant
Subsequent follow-up visits will be at 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months after intravitreal injection of dexamethasone implant
Each visit will consist of measurement of visual acuity, intraocular pressure, dilated fundoscopic examination, and SD-OCT scan
Anticipated duration of the study: 6 months
arm group label: 0.7mg dexamethasone intravitreal implant
other name: Ozurdex
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Allen C Ho, MD
role: Principal Investigator
affiliation: Mid Atlantic Retina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wills Eye
investigator full name: Allen C. Ho, MD
investigator title: MD
mesh term: Macular Edema
mesh term: Epiretinal Membrane
mesh term: Edema
mesh term: Dexamethasone
sharing ipd: No
submitted: January 15, 2019
returned: February 6, 2019