<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/NCT01698788</url>
  </required_header>
  <id_info>
    <org_study_id>dr.poojabansal</org_study_id>
    <nct_id>NCT01698788</nct_id>
  </id_info>
  <brief_title>Effect of Intraoperative Dexamethasone Implant in Taut Posterior Hyaloid Removal in Diabetic Macular Edema</brief_title>
  <official_title>Role of Intraoperative Dexamethasone Implant in Improving Outcome of Taut Posterior Hyaloid Removal in 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 effect of sustained release dexamethasone&#xD;
      implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with&#xD;
      diabetic macular edema&#xD;
&#xD;
      Diabetic macular edema constitute important cause of visual impairment in patients with&#xD;
      diabetes.Focal/ grid laser photocoagulation is the standard of care in the management .&#xD;
      Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab ,&#xD;
      Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections&#xD;
      macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs&#xD;
      to be removed by vitrectomy. Visual improvement after vitrectomy is related to the duration&#xD;
      of edema, as well as the extent of intraretinal lipid and vascular nonperfusion.Even after&#xD;
      surgery some patients might need repeat intravitreal bevacizumab or triamcinolone injections&#xD;
      to take care of residual macular edema.Intravitreal Triamcinolone Acetonide (TA), a water&#xD;
      insoluble steroid, has been shown to reduce the retinal thickness and improve the visual&#xD;
      acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a&#xD;
      major concern because of its short half life . In search for the ideal corticosteroid&#xD;
      preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS -&#xD;
      Ozurdex®, Allergan Inc, Irvine, California) was recently developed which has generated new&#xD;
      interest in this molecule. It is a sustained release intravitreal implant containing 700µg&#xD;
      dexamethasone has been approved by the US-FDA (Food and Drug Administration) for treatment of&#xD;
      macular edema in retinal vein occlusions. The present study introduces a novel concept of&#xD;
      using intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect&#xD;
      in improving the surgical outcome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is undertaken to determine effect of sustained release dexamethasone&#xD;
      implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with&#xD;
      diabetic macular edema&#xD;
&#xD;
      Diabetic macular edema constitute important cause of visual impairment in patients with&#xD;
      diabetes.Focal/ grid laser photocoagulation is the standard of care in the management&#xD;
      .Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab ,&#xD;
      Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections&#xD;
      macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs&#xD;
      to be removed by vitrectomy. The exact role of vitreous in the pathogenesis of diabetic&#xD;
      maculopathy remains unclear although it has been implicated as a cause of macular edema via&#xD;
      several mechanical and physiologic mechanisms, which include the following (1)&#xD;
      destabilization of the vitreous by abnormal glycation and crosslinking of vitreal collagen,&#xD;
      leading to traction on the macula, (2) accumulation and concentration of factors causing&#xD;
      vasopermeability in the premacular vitreous gel and (3) accumulation of chemoattractant&#xD;
      factors in the vitreous, leading to cellular migration to the posterior hyaloid, contraction&#xD;
      and macular traction. The observation that release of mechanical traction on the macula with&#xD;
      subsequent reduction in DME, either by spontaneous posterior vitreous detachment or with&#xD;
      vitrectomy, lends support to this line of reasoning. Furthermore, the evidence that&#xD;
      vitrectomy produces improved retinal oxygenation taken together with the evidence that&#xD;
      increased oxygenation can reduce DME, suggests an additional physiologic advantage but&#xD;
      determination of which eyes might benefit from vitrectomy is the most challenging aspect in&#xD;
      the treatment of this condition. Fluorescein angiography, B-scan ultrasonography, and optical&#xD;
      coherence tomography may be helpful in this regard. Most often, vitreous surgery is performed&#xD;
      when diabetic macular edema persists despite multiple laser treatments. All reports published&#xD;
      to date regarding vitrectomy for diabetic macular edema are uncontrolled and nonrandomized&#xD;
      patient series. Visual improvement after vitrectomy is related to the duration of edema, as&#xD;
      well as the extent of intraretinal lipid and vascular nonperfusion.Even after surgery some&#xD;
      patients might need repeat intravitreal bevacizumab or triamcinolone injections to take care&#xD;
      of residual macular edema.Intravitreal Triamcinolone Acetonide (TA), a water insoluble&#xD;
      steroid, has been shown to reduce the retinal thickness and improve the visual acuity.&#xD;
      However, recurrence of macular edema in patients who receive intravitreal TA is a major&#xD;
      concern because of its short half life . In search for the ideal corticosteroid preparation,&#xD;
      a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®,&#xD;
      Allergan Inc, Irvine, California) was recently developed which has generated new interest in&#xD;
      this molecule. It is a sustained release intravitreal implant containing 700µg dexamethasone&#xD;
      has been approved by the US-FDA (Food and Drug Administration) for treatment of macular edema&#xD;
      in retinal vein occlusions. The present study introduces a novel concept of using&#xD;
      intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect in&#xD;
      improving the surgical outcome&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>N/A</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>
    <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 to 3 months</time_frame>
    <description>The primary outcome measure is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in visual acuity</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Change in the visual acuity as measured by the logMAR visual acuity chart</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <condition>Vision Disorders</condition>
  <arm_group>
    <arm_group_label>TPHM removal without ozurdex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison of taut posterior hyaloid removal with (Group B)and without intraoperative ozurdex(Group A)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TPHM removal with ozurdex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison of TPHM removal with (Group B) and without (Group A)Ozurdex</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Drug delivery system (Ozurdex)</intervention_name>
    <description>It is a sustained release intravitreal implant containing 700µg dexamethasone</description>
    <arm_group_label>TPHM removal with ozurdex</arm_group_label>
    <arm_group_label>TPHM removal without ozurdex</arm_group_label>
    <other_name>OZURDEX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Type 1 or 2 Diabetes mellitus&#xD;
&#xD;
          2. TPHM causing cystoid macular edema with or without subfoveal serous RD on OCT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known case of ocular hypertension or glaucoma&#xD;
&#xD;
          2. Macular ischemia on FFA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>65 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>diabetic macular edema</keyword>
  <keyword>taut posterior hyaloid membrane</keyword>
  <keyword>ozurdex</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>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</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/NCT01698788
org study id: dr.poojabansal
nct id: NCT01698788
lead sponsor: 
has dmc: No
This study is undertaken to determine effect of sustained release dexamethasone
      implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with
      diabetic macular edema

      Diabetic macular edema constitute important cause of visual impairment in patients with
      diabetes.Focal/ grid laser photocoagulation is the standard of care in the management .
      Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab ,
      Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections
      macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs
      to be removed by vitrectomy. Visual improvement after vitrectomy is related to the duration
      of edema, as well as the extent of intraretinal lipid and vascular nonperfusion.Even after
      surgery some patients might need repeat intravitreal bevacizumab or triamcinolone injections
      to take care of residual macular edema.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 because of its short half life . In search for the ideal corticosteroid
      preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS -
      Ozurdex®, Allergan Inc, Irvine, California) was recently developed which has generated new
      interest in this molecule. It is a sustained release intravitreal implant containing 700µg
      dexamethasone has been approved by the US-FDA (Food and Drug Administration) for treatment of
      macular edema in retinal vein occlusions. The present study introduces a novel concept of
      using intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect
      in improving the surgical outcome
This study is undertaken to determine effect of sustained release dexamethasone
      implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with
      diabetic macular edema

      Diabetic macular edema constitute important cause of visual impairment in patients with
      diabetes.Focal/ grid laser photocoagulation is the standard of care in the management
      .Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab ,
      Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections
      macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs
      to be removed by vitrectomy. The exact role of vitreous in the pathogenesis of diabetic
      maculopathy remains unclear although it has been implicated as a cause of macular edema via
      several mechanical and physiologic mechanisms, which include the following (1)
      destabilization of the vitreous by abnormal glycation and crosslinking of vitreal collagen,
      leading to traction on the macula, (2) accumulation and concentration of factors causing
      vasopermeability in the premacular vitreous gel and (3) accumulation of chemoattractant
      factors in the vitreous, leading to cellular migration to the posterior hyaloid, contraction
      and macular traction. The observation that release of mechanical traction on the macula with
      subsequent reduction in DME, either by spontaneous posterior vitreous detachment or with
      vitrectomy, lends support to this line of reasoning. Furthermore, the evidence that
      vitrectomy produces improved retinal oxygenation taken together with the evidence that
      increased oxygenation can reduce DME, suggests an additional physiologic advantage but
      determination of which eyes might benefit from vitrectomy is the most challenging aspect in
      the treatment of this condition. Fluorescein angiography, B-scan ultrasonography, and optical
      coherence tomography may be helpful in this regard. Most often, vitreous surgery is performed
      when diabetic macular edema persists despite multiple laser treatments. All reports published
      to date regarding vitrectomy for diabetic macular edema are uncontrolled and nonrandomized
      patient series. Visual improvement after vitrectomy is related to the duration of edema, as
      well as the extent of intraretinal lipid and vascular nonperfusion.Even after surgery some
      patients might need repeat intravitreal bevacizumab or triamcinolone injections to take care
      of residual macular edema.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 because of its short half life . In search for the ideal corticosteroid preparation,
      a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®,
      Allergan Inc, Irvine, California) was recently developed which has generated new interest in
      this molecule. It is a sustained release intravitreal implant containing 700µg dexamethasone
      has been approved by the US-FDA (Food and Drug Administration) for treatment of macular edema
      in retinal vein occlusions. The present study introduces a novel concept of using
      intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect in
      improving the surgical outcome
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in central macular thickness
time frame: Baseline to 3 months
description: The primary outcome measure is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness
measure: change in visual acuity
time frame: Baseline to 3 months
description: Change in the visual acuity as measured by the logMAR visual acuity chart
arm group label: TPHM removal without ozurdex
arm group type: Experimental
description: Comparison of taut posterior hyaloid removal with (Group B)and without intraoperative ozurdex(Group A)
arm group label: TPHM removal with ozurdex
arm group type: Experimental
description: Comparison of TPHM removal with (Group B) and without (Group A)Ozurdex
intervention type: Drug
intervention name: Dexamethasone Drug delivery system (Ozurdex)
description: It is a sustained release intravitreal implant containing 700µg dexamethasone
arm group label: TPHM removal with ozurdex
arm group label: TPHM removal without ozurdex
other name: OZURDEX
criteria: 
gender: All
minimum age: 60 Years
maximum age: 65 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
mesh term: Dexamethasone acetate
mesh term: BB 1101