<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/NCT01662518</url>
  </required_header>
  <id_info>
    <org_study_id>Bramets-01</org_study_id>
    <nct_id>NCT01662518</nct_id>
  </id_info>
  <brief_title>DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)</brief_title>
  <acronym>DDS-25</acronym>
  <official_title>A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro de Pesquisa Rubens Siqueira</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro de Pesquisa Rubens Siqueira</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone&#xD;
      (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and&#xD;
      optical coherence tomography in 10 patients with macular edema associated with retinal vein&#xD;
      occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>intervention group: 25-gauge biodegradable implant containing 350 μg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>Day 0 - Day 180</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in central foveal thickness at 48 weeks</measure>
    <time_frame>1 day to 48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Macular Edema</condition>
  <condition>Retinal Vein Occlusion</condition>
  <arm_group>
    <arm_group_label>DDS-25</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravitreal injection of DDS-25(Dexamethasone drug delivery system )</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexamethasone drug delivery system (DDS-25)</intervention_name>
    <description>350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline</description>
    <arm_group_label>DDS-25</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older with macular edema resulting from retinal vein occlusion&#xD;
&#xD;
          -  Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or&#xD;
             worse)&#xD;
&#xD;
          -  Visual acuity in other eye no worse than 20/200&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known anticipated need for ocular surgery within next 12 months&#xD;
&#xD;
          -  History of glaucoma or current high eye pressure requiring more than 1 medication&#xD;
&#xD;
          -  Diabetic retinopathy&#xD;
&#xD;
          -  Uncontrolled systemic disease&#xD;
&#xD;
          -  Known steroid-responder&#xD;
&#xD;
          -  Use of systemic steroids&#xD;
&#xD;
          -  Use of warfarin/heparin&#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>Rubens C Siqueira, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro de Pesquisa Rubens Siqueira</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Pesquisa Rubens Siqueira</name>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <state>SP</state>
        <zip>15010-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27632583</url>
    <description>SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL.</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro de Pesquisa Rubens Siqueira</investigator_affiliation>
    <investigator_full_name>Rubens Camargo Siqueira</investigator_full_name>
    <investigator_title>MD,PhD - Principal Investigator</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>Retinal Vein Occlusion</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>Yes</sharing_ipd>
    <ipd_description>Retin Cases Brief Rep. 2016 Sep 14. [Epub ahead of print] SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL.&#xD;
Cunha RB1, Siqueira RC, Messias A, Scott IU, Fialho SL, Cunha-Junior AD, Jorge R.</ipd_description>
  </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/NCT01662518
org study id: Bramets-01
nct id: NCT01662518
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone
      (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.
Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and
      optical coherence tomography in 10 patients with macular edema associated with retinal vein
      occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: intervention group: 25-gauge biodegradable implant containing 350 μg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion.
primary purpose: Treatment
masking: None (Open Label)
measure: Best Corrected Visual Acuity (BCVA)
time frame: Day 0 - Day 180
measure: Change in central foveal thickness at 48 weeks
time frame: 1 day to 48 weeks
arm group label: DDS-25
arm group type: Experimental
description: Intravitreal injection of DDS-25(Dexamethasone drug delivery system )
intervention type: Device
intervention name: Dexamethasone drug delivery system (DDS-25)
description: 350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline
arm group label: DDS-25
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rubens C Siqueira, MD,PhD
role: Principal Investigator
affiliation: Centro de Pesquisa Rubens Siqueira
facility: 
country: Brazil
url: http://www.ncbi.nlm.nih.gov/pubmed/27632583
description: SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL.
responsible party type: Principal Investigator
investigator affiliation: Centro de Pesquisa Rubens Siqueira
investigator full name: Rubens Camargo Siqueira
investigator title: MD,PhD - Principal Investigator
mesh term: Macular Edema
mesh term: Retinal Vein Occlusion
mesh term: Edema
mesh term: Dexamethasone
sharing ipd: Yes
ipd description: Retin Cases Brief Rep. 2016 Sep 14. [Epub ahead of print] SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL.
Cunha RB1, Siqueira RC, Messias A, Scott IU, Fialho SL, Cunha-Junior AD, Jorge R.