<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/NCT01698749</url>
  </required_header>
  <id_info>
    <org_study_id>PoojaBansal 13</org_study_id>
    <nct_id>NCT01698749</nct_id>
  </id_info>
  <brief_title>Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema</brief_title>
  <official_title>Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is undertaken to determine the effect of intravitreal long acting dexamethasone&#xD;
      implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important&#xD;
      cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser&#xD;
      photocoagulation is the standard of care in its management. Several adjuncts including&#xD;
      intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal&#xD;
      anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.&#xD;
      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to&#xD;
      reduce the retinal thickness and improve the visual acuity. However, recurrence of macular&#xD;
      edema in patients who receive intravitreal TA is a major concern as the patients need&#xD;
      multiple repeat injections because of its short half life. A more potent steroid,&#xD;
      dexamethasone has also been tried as an alternative to TA for macular edema; however, its&#xD;
      short half life of only 3 hours prevents its clinical application. In search for the ideal&#xD;
      corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System&#xD;
      (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.&#xD;
      Promising results have been shown in certain patients with retinal vein occlusions, uveitis&#xD;
      receiving this intravitreal drug delivery system with improvement in visual acuity. The&#xD;
      present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic&#xD;
      macular edema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is undertaken to determine the effect of intravitreal long acting dexamethasone&#xD;
      implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important&#xD;
      cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser&#xD;
      photocoagulation is the standard of care in its management. Several adjuncts including&#xD;
      intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal&#xD;
      anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.&#xD;
      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to&#xD;
      reduce the retinal thickness and improve the visual acuity. However, recurrence of macular&#xD;
      edema in patients who receive intravitreal TA is a major concern as the patients need&#xD;
      multiple repeat injections because of its short half life. A more potent steroid,&#xD;
      dexamethasone has also been tried as an alternative to TA for macular edema; however, its&#xD;
      short half life of only 3 hours prevents its clinical application. In search for the ideal&#xD;
      corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System&#xD;
      (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.&#xD;
      Promising results have been shown in certain patients with retinal vein occlusions, uveitis&#xD;
      receiving this intravitreal drug delivery system with improvement in visual acuity. The&#xD;
      present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic&#xD;
      macular edema.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</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>change in central macular thickness</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to baseline central macular thickness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the visual acuity</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Change in the visual acuity as measured by the logMAR visual acuity chart</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <condition>Macular Edema, Cystoid</condition>
  <condition>Vision Disorders</condition>
  <condition>Clinically Significant Macular Edema</condition>
  <arm_group>
    <arm_group_label>Ozurdex in diabetic macular edema</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravitreal ozurdex given in patients with diabetic macular edema and patients followed up for change in central macular thickness and visual acuity over period of 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>long acting intravitreal dexamethasone implant</intervention_name>
    <description>Intravitreal ozurdex was given in diabetic patients with clinically significant macular edema and they were followed up for change in central macular thickness and visual acuity over a period of 6 months</description>
    <arm_group_label>Ozurdex in diabetic macular edema</arm_group_label>
    <other_name>Ozurdex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion&#xD;
             criteria shall be enrolled in the study:&#xD;
&#xD;
               1. Patients of Non Proliferative Diabetic retinopathy (NPDR)with clinicaly&#xD;
                  significant macular edema(CSME)&#xD;
&#xD;
               2. Patients with Proliferative Diabetic Retinopathy (PDR) with CSME where&#xD;
                  proliferative component has been adequately treated with laser photocoagulation&#xD;
&#xD;
               3. Diabetic patients withcystoid macular edema&#xD;
&#xD;
               4. Minimum central thickness on OCT not less than 300 microns&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with history of ocular hypertension or glaucoma&#xD;
&#xD;
          2. Patients with media haze or pupillary non-dilation that does not allow good fundus&#xD;
             photography, FFA and OCT.&#xD;
&#xD;
          3. Patients with macular ischemia on FFA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>POOJA BANSAL, MBBS,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Postgraduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>VISHALI R GUPTA, MBBS,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Postgraduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>AMOD GUPTA, MBBS,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Postgraduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pooja Bansal</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>March 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 29, 2012</last_update_submitted>
  <last_update_submitted_qc>September 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Pooja Bansal,MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Ozurdex</keyword>
  <keyword>Diabetic macular edema</keyword>
  <keyword>Central macular thickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision Disorders</mesh_term>
    <mesh_term>Macular Edema</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>
  <!-- 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/NCT01698749
org study id: PoojaBansal 13
nct id: NCT01698749
lead sponsor: 
has dmc: No
This study is undertaken to determine the effect of intravitreal long acting dexamethasone
      implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important
      cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser
      photocoagulation is the standard of care in its management. Several adjuncts including
      intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal
      anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.
      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to
      reduce the retinal thickness and improve the visual acuity. However, recurrence of macular
      edema in patients who receive intravitreal TA is a major concern as the patients need
      multiple repeat injections because of its short half life. A more potent steroid,
      dexamethasone has also been tried as an alternative to TA for macular edema; however, its
      short half life of only 3 hours prevents its clinical application. In search for the ideal
      corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System
      (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.
      Promising results have been shown in certain patients with retinal vein occlusions, uveitis
      receiving this intravitreal drug delivery system with improvement in visual acuity. The
      present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic
      macular edema.
This study is undertaken to determine the effect of intravitreal long acting dexamethasone
      implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important
      cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser
      photocoagulation is the standard of care in its management. Several adjuncts including
      intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal
      anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.
      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to
      reduce the retinal thickness and improve the visual acuity. However, recurrence of macular
      edema in patients who receive intravitreal TA is a major concern as the patients need
      multiple repeat injections because of its short half life. A more potent steroid,
      dexamethasone has also been tried as an alternative to TA for macular edema; however, its
      short half life of only 3 hours prevents its clinical application. In search for the ideal
      corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System
      (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.
      Promising results have been shown in certain patients with retinal vein occlusions, uveitis
      receiving this intravitreal drug delivery system with improvement in visual acuity. The
      present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic
      macular edema.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in central macular thickness
time frame: Baseline and 6 months
description: The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to baseline central macular thickness
measure: Change in the visual acuity
time frame: Baseline and 6 months
description: Change in the visual acuity as measured by the logMAR visual acuity chart
arm group label: Ozurdex in diabetic macular edema
arm group type: Experimental
description: Intravitreal ozurdex given in patients with diabetic macular edema and patients followed up for change in central macular thickness and visual acuity over period of 6 months
intervention type: Drug
intervention name: long acting intravitreal dexamethasone implant
description: Intravitreal ozurdex was given in diabetic patients with clinically significant macular edema and they were followed up for change in central macular thickness and visual acuity over a period of 6 months
arm group label: Ozurdex in diabetic macular edema
other name: Ozurdex
criteria: 
gender: All
minimum age: 20 Years
maximum age: 72 Years
healthy volunteers: Accepts Healthy Volunteers
last name: POOJA BANSAL, MBBS,MS
role: Principal Investigator
affiliation: Postgraduate Institute of Medical Education and Research
last name: VISHALI R GUPTA, MBBS,MS
role: Principal Investigator
affiliation: Postgraduate Institute of Medical Education and Research
last name: AMOD GUPTA, MBBS,MS
role: Principal Investigator
affiliation: Postgraduate Institute of Medical Education and Research
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Pooja Bansal,MD
investigator title: MD
mesh term: Vision Disorders
mesh term: Macular Edema
mesh term: Edema
mesh term: Dexamethasone