<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/NCT04501367</url>
  </required_header>
  <id_info>
    <org_study_id>Kovacheye</org_study_id>
    <nct_id>NCT04501367</nct_id>
  </id_info>
  <brief_title>Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.</brief_title>
  <official_title>Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kovach Eye Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kovach Eye Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts&#xD;
      following 27 gauge vitrectomy with internal limiting membrane peel&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg&#xD;
      inserts, when placed within the lower eye lid canaliculus or both the upper and lower&#xD;
      canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27&#xD;
      gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema&#xD;
      associated with macular pucker&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 27, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>In patients who undergo vitrectomy with internal limiting membrane peel surgery , subjects will be randomized to three groups and be followed for a period of two months. One group will be selected to receive one DEXTENZA (in the lower canaliculus), the second group will receive two DEXTENZA (upper and lower canaliculi) and the third group will receive prednisolone acetate 1% (control eye) . All groups will receive a subconjunctival dexamethasone injection at the time of surgery.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in retina edema</measure>
    <time_frame>assessed on day 30 and day 60</time_frame>
    <description>As measured by Optical Coherence Tomography (OCT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in Inflammation ( Cell and Flare)</measure>
    <time_frame>as assessed on days 1, 7, 30, 60</time_frame>
    <description>As measured by SUN (Standardization of Uveitis Nomenclature) grading scale;absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of 0-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in pain scores</measure>
    <time_frame>as assessed on days 1, 7, 30, 60</time_frame>
    <description>as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Best- Corrected Visual Acuity (BCVA)</measure>
    <time_frame>from baseline at days 1, 7, 30, 60</time_frame>
    <description>as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician ease of Dextenza insertion</measure>
    <time_frame>as assessed on day of surgery</time_frame>
    <description>measured by a 0-10 scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Vitrectomy</condition>
  <condition>Macular Pucker</condition>
  <condition>Retinal Edema</condition>
  <arm_group>
    <arm_group_label>DEXTENZA Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing vitrectomy with internal limiting membrane peel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second DEXTENZA Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing vitrectomy with internal limiting membrane peel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical Prednisolone Acetate 1% Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing vitrectomy with internal limiting membrane peel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Intracanalicular Insert, 0.4 mg</intervention_name>
    <description>To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery</description>
    <arm_group_label>DEXTENZA Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Intracanalicular Insert, 0.4 mg</intervention_name>
    <description>To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery</description>
    <arm_group_label>Second DEXTENZA Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone acetate 1%</intervention_name>
    <description>To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery</description>
    <arm_group_label>Topical Prednisolone Acetate 1% Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible&#xD;
        for inclusion in the study:&#xD;
&#xD;
          -  Symptomatic macular pucker with retinal edema&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Scheduled vitrectomy and internal limiting membrane peel&#xD;
&#xD;
          -  Willing and able to comply with clinic visits and study related procedures&#xD;
&#xD;
          -  Willing and able to sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria: A patient who meets any of the following criteria will be excluded from&#xD;
        the study:&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)&#xD;
&#xD;
          -  Active infectious systemic disease&#xD;
&#xD;
          -  Active infectious ocular or extraocular disease&#xD;
&#xD;
          -  Obstructed nasolacrimal duct in the study eye (s)&#xD;
&#xD;
          -  Hypersensitivity to dexamethasone or prednisolone eye drops&#xD;
&#xD;
          -  Patients being treated with immunomodulating agents in the study eye(s)&#xD;
&#xD;
          -  Patient being treated with immunosuppressants and/or oral steroids&#xD;
&#xD;
          -  Patients with severe disease that warrants critical attention, deemed unsafe for the&#xD;
             study by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saad Ahmad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kovach Eye Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Saad Ahmad, MD</last_name>
    <phone>6308339361</phone>
    <email>ifixretinas@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jamie White, Bachelors</last_name>
    <phone>6308339621</phone>
    <email>jamie.white@kovacheye.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kovach Eye Institute</name>
      <address>
        <city>Elmhurst</city>
        <state>Illinois</state>
        <zip>60126</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jamie White, BA</last_name>
      <phone>630-833-9361</phone>
      <phone_ext>129</phone_ext>
      <email>jamie.white@kovacheye.com</email>
    </contact>
    <investigator>
      <last_name>Saad Ahmad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papilledema</mesh_term>
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Epiretinal Membrane</mesh_term>
    <mesh_term>Inflammation</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>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>BB 1101</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/NCT04501367
org study id: Kovacheye
nct id: NCT04501367
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts
      following 27 gauge vitrectomy with internal limiting membrane peel
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg
      inserts, when placed within the lower eye lid canaliculus or both the upper and lower
      canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27
      gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema
      associated with macular pucker
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In patients who undergo vitrectomy with internal limiting membrane peel surgery , subjects will be randomized to three groups and be followed for a period of two months. One group will be selected to receive one DEXTENZA (in the lower canaliculus), the second group will receive two DEXTENZA (upper and lower canaliculi) and the third group will receive prednisolone acetate 1% (control eye) . All groups will receive a subconjunctival dexamethasone injection at the time of surgery.
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change in retina edema
time frame: assessed on day 30 and day 60
description: As measured by Optical Coherence Tomography (OCT)
measure: Mean change in Inflammation ( Cell and Flare)
time frame: as assessed on days 1, 7, 30, 60
description: As measured by SUN (Standardization of Uveitis Nomenclature) grading scale;absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of 0-1
measure: Mean change in pain scores
time frame: as assessed on days 1, 7, 30, 60
description: as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible
measure: Mean Change in Best- Corrected Visual Acuity (BCVA)
time frame: from baseline at days 1, 7, 30, 60
description: as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart
measure: Physician ease of Dextenza insertion
time frame: as assessed on day of surgery
description: measured by a 0-10 scale
arm group label: DEXTENZA Group
arm group type: Experimental
description: Patients undergoing vitrectomy with internal limiting membrane peel
arm group label: Second DEXTENZA Group
arm group type: Experimental
description: Patients undergoing vitrectomy with internal limiting membrane peel
arm group label: Topical Prednisolone Acetate 1% Group
arm group type: Experimental
description: Patients undergoing vitrectomy with internal limiting membrane peel
intervention type: Drug
intervention name: Dexamethasone Intracanalicular Insert, 0.4 mg
description: To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
arm group label: DEXTENZA Group
intervention type: Drug
intervention name: Dexamethasone Intracanalicular Insert, 0.4 mg
description: To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
arm group label: Second DEXTENZA Group
intervention type: Drug
intervention name: Prednisone acetate 1%
description: To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
arm group label: Topical Prednisolone Acetate 1% Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Saad Ahmad, MD
role: Principal Investigator
affiliation: Kovach Eye Institute
last name: Saad Ahmad, MD
phone: 6308339361
email: ifixretinas@gmail.com
last name: Jamie White, Bachelors
phone: 6308339621
email: jamie.white@kovacheye.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Papilledema
mesh term: Macular Edema
mesh term: Epiretinal Membrane
mesh term: Inflammation
mesh term: Edema
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Prednisone
mesh term: BB 1101
sharing ipd: No