<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/NCT04448496</url>
  </required_header>
  <id_info>
    <org_study_id>YUMC 2020-05-086</org_study_id>
    <nct_id>NCT04448496</nct_id>
  </id_info>
  <brief_title>Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema</brief_title>
  <acronym>DANTE</acronym>
  <official_title>Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema: The Multicenter DANTE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeungnam University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeungnam University College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the investigator's study is to evaluate the efﬁcacy and safety proﬁle of the&#xD;
      pro re nata (PRN) regimen to 12 months by using intravitreal dexamethasone implant in eyes&#xD;
      with treatment-naive diabetic macular edema patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pathogenesis of diabetic macular edema (DME) involves inflammation, angiogenesis, and&#xD;
      oxidative stress processes provoked mainly by cytokines such as interleukin (IL)-6, 8, and&#xD;
      monocyte chemotactic protein, and vascular endothelial growth factor (VEGF). Vision loss&#xD;
      associated with diabetic retinopathy is most commonly caused by DME, which affects&#xD;
      approximately 7% of all diabetic patients. Several therapeutic options are available for&#xD;
      treating DME. Evidence for the use of these therapies is accumulating; however, the optical&#xD;
      treatment choice remains unclear. In recent years, using intravitreal anti-VEGF agents to&#xD;
      treat DME has been shown to be beneficial. Anti-VEGF injections are generally considered&#xD;
      suitable first-line therapy for center-involved DME and are effective in improving visual&#xD;
      acuity (VA), with 10% to 40% of patients achieving significant improvement in best-corrected&#xD;
      visual acuity (BCVA) after 1 year of treatment.&#xD;
&#xD;
      The management of DME is complex, and often multiple treatment approaches are needed.&#xD;
      Although anti-VEGF agents were effective for the treatment of DME, there is a proportion of&#xD;
      patients who do not achieve optimal response to these agents, presenting refractory or&#xD;
      persistent DME. Intravitreal administration of steroids for the treatment of DME has also&#xD;
      been studied for many years due to their well-known, widespread, anti-inflammatory effects.&#xD;
      Dexamethasone implant is a slow-release dexamethasone delivery system developed for&#xD;
      intravitreal administration that has recently been introduced as a therapeutic option in DME.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 22, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 4</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 change of best corrected visual acuity</measure>
    <time_frame>From baseline to month 6</time_frame>
    <description>The mean change of best corrected visual acuity from baseline to Month 6 in early treatment diabetic retinopathy (ETDRS) letter score by using Logarithm of the Minimum Angle of Resolution (LogMAR) chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change of best corrected visual acuity</measure>
    <time_frame>From baseline to month 12</time_frame>
    <description>The change in mean best corrected visual acuity at baseline as measured by the early treatment diabetic retinopathy letter score by using Logarithm of the Minimum Angle of Resolution (LogMAR) chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in central macular thickness</measure>
    <time_frame>From baseline to month 6 and 12</time_frame>
    <description>The mean change in central macular thickness (um) by using optical coherence tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of injections</measure>
    <time_frame>From baseline to month 12</time_frame>
    <description>The mean number of injections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean treatment interval between injections</measure>
    <time_frame>From baseline to month 12</time_frame>
    <description>The mean treatment interval (weeks) between injections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion (%) of subjects who gain ≥ 15 letters in best corrected visual acuity</measure>
    <time_frame>Compared with baseline at month 6 and 12</time_frame>
    <description>The proportion (%) of subjects who gain ≥ 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of total area (mm^2)of nonperfusion within the ETDRS grid using fluorescein angiography and optical coherence tomography angiography</measure>
    <time_frame>From baseline to month 12</time_frame>
    <description>Changes of total area (mm^2) of nonperfusion within the ETDRS grid using fluorescein angiography and optical coherence tomography angiography</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">49</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>Arms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetic macular edema Dexamethasone 0.7mg is injected into the vitreous cavity. Center-involved macular edema secondary to diabetic retinopathy for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone implant</intervention_name>
    <description>Dexamethasone 0.7mg is injected into the vitreous cavity through the pars plana using applicator for diabetic macular edema.</description>
    <arm_group_label>Arms</arm_group_label>
    <other_name>Ozurdex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and females 18 years of age or older&#xD;
&#xD;
          2. Written informed consent has been obtained&#xD;
&#xD;
          3. Diabetic macular edema with a central macular thickness (CMT) ≥ 300um measured by&#xD;
             spectral domain optical coherence tomography.&#xD;
&#xD;
          4. Treatment-naïve subjects for diabetic macular edema.&#xD;
&#xD;
          5. Documented BCVA of ETDRS letter score of 23 to 73 letters (Snellen equivalent of&#xD;
             20/320 to 20/40) in the study eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous panretinal photocoagulation (PRP) or macular laser photocoagulation in the&#xD;
             study eye&#xD;
&#xD;
          2. Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in&#xD;
             the study eye for diabetic macular edema&#xD;
&#xD;
          3. Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved,&#xD;
             within the last 3 months before the first dose in the study&#xD;
&#xD;
          4. Previous use of intraocular corticosteroids in the study eye at any time or use of&#xD;
             periocular corticosteroids in the study eye within 12 months prior to Day 1&#xD;
&#xD;
          5. Elevated intraocular pressure or a history of steroid-induced ocular hypertension&#xD;
&#xD;
          6. The presence of other retinopathies, maculopathies, visually signiﬁcant cataract,&#xD;
             vitreomacular traction, peripheral ischemia, history of pars plana vitrectomy&#xD;
&#xD;
          7. Any active intraocular, extraocular, and periocular inflammation or infection in&#xD;
             either eye within 4 weeks of screening&#xD;
&#xD;
          8. Any history of allergy to povidone iodine&#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>Min Sagong, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yeungnam University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min Sagong, MD,PhD</last_name>
    <phone>82-53-620-3443</phone>
    <email>msagong@ynu.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sohee Shin</last_name>
    <phone>82-53-620-3877</phone>
    <email>ey005@ymc.yu.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dong-A University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Woo Jin Jung, MD,PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maryknoll Medical Center</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jung Min Park, MD,PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gyeongsang National University Changwon Hospital</name>
      <address>
        <city>Changwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong Seop Han, MD,PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yeungnam university hospital</name>
      <address>
        <city>Daegu</city>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Min Sagong, MD,PhD</last_name>
      <phone>82-53-620-3443</phone>
      <email>msagong@ynu.ac.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dong Ho Park, MD,PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jung Yeul Kim, MD,PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong Sok Ji, MD,PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yeungnam University College of Medicine</investigator_affiliation>
    <investigator_full_name>Min Sagong</investigator_full_name>
    <investigator_title>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>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</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/NCT04448496
org study id: YUMC 2020-05-086
nct id: NCT04448496
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of the investigator's study is to evaluate the efﬁcacy and safety proﬁle of the
      pro re nata (PRN) regimen to 12 months by using intravitreal dexamethasone implant in eyes
      with treatment-naive diabetic macular edema patients.
Pathogenesis of diabetic macular edema (DME) involves inflammation, angiogenesis, and
      oxidative stress processes provoked mainly by cytokines such as interleukin (IL)-6, 8, and
      monocyte chemotactic protein, and vascular endothelial growth factor (VEGF). Vision loss
      associated with diabetic retinopathy is most commonly caused by DME, which affects
      approximately 7% of all diabetic patients. Several therapeutic options are available for
      treating DME. Evidence for the use of these therapies is accumulating; however, the optical
      treatment choice remains unclear. In recent years, using intravitreal anti-VEGF agents to
      treat DME has been shown to be beneficial. Anti-VEGF injections are generally considered
      suitable first-line therapy for center-involved DME and are effective in improving visual
      acuity (VA), with 10% to 40% of patients achieving significant improvement in best-corrected
      visual acuity (BCVA) after 1 year of treatment.

      The management of DME is complex, and often multiple treatment approaches are needed.
      Although anti-VEGF agents were effective for the treatment of DME, there is a proportion of
      patients who do not achieve optimal response to these agents, presenting refractory or
      persistent DME. Intravitreal administration of steroids for the treatment of DME has also
      been studied for many years due to their well-known, widespread, anti-inflammatory effects.
      Dexamethasone implant is a slow-release dexamethasone delivery system developed for
      intravitreal administration that has recently been introduced as a therapeutic option in DME.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change of best corrected visual acuity
time frame: From baseline to month 6
description: The mean change of best corrected visual acuity from baseline to Month 6 in early treatment diabetic retinopathy (ETDRS) letter score by using Logarithm of the Minimum Angle of Resolution (LogMAR) chart
measure: Mean change of best corrected visual acuity
time frame: From baseline to month 12
description: The change in mean best corrected visual acuity at baseline as measured by the early treatment diabetic retinopathy letter score by using Logarithm of the Minimum Angle of Resolution (LogMAR) chart
measure: Mean change in central macular thickness
time frame: From baseline to month 6 and 12
description: The mean change in central macular thickness (um) by using optical coherence tomography
measure: Mean number of injections
time frame: From baseline to month 12
description: The mean number of injections
measure: Mean treatment interval between injections
time frame: From baseline to month 12
description: The mean treatment interval (weeks) between injections
measure: Proportion (%) of subjects who gain ≥ 15 letters in best corrected visual acuity
time frame: Compared with baseline at month 6 and 12
description: The proportion (%) of subjects who gain ≥ 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart
measure: Changes of total area (mm^2)of nonperfusion within the ETDRS grid using fluorescein angiography and optical coherence tomography angiography
time frame: From baseline to month 12
description: Changes of total area (mm^2) of nonperfusion within the ETDRS grid using fluorescein angiography and optical coherence tomography angiography
arm group label: Arms
arm group type: Experimental
description: Diabetic macular edema Dexamethasone 0.7mg is injected into the vitreous cavity. Center-involved macular edema secondary to diabetic retinopathy for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit)
intervention type: Drug
intervention name: Dexamethasone implant
description: Dexamethasone 0.7mg is injected into the vitreous cavity through the pars plana using applicator for diabetic macular edema.
arm group label: Arms
other name: Ozurdex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Min Sagong, MD,PhD
role: Principal Investigator
affiliation: Yeungnam University Hospital
last name: Min Sagong, MD,PhD
phone: 82-53-620-3443
email: msagong@ynu.ac.kr
last name: Sohee Shin
phone: 82-53-620-3877
email: ey005@ymc.yu.ac.kr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yeungnam University College of Medicine
investigator full name: Min Sagong
investigator title: Professor
mesh term: Macular Edema
mesh term: Diabetic Retinopathy
mesh term: Dexamethasone