<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/NCT02221453</url>
  </required_header>
  <id_info>
    <org_study_id>PersDMEcytokineTA</org_study_id>
    <nct_id>NCT02221453</nct_id>
  </id_info>
  <brief_title>Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide</brief_title>
  <official_title>Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide: an Interventional Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.&#xD;
      The retina is like the film of a camera and is located in the back of the eye. This condition&#xD;
      can develop in diabetics where swelling results from leaking of fluid from the blood vessels&#xD;
      of the eye, into the center of the retina, the macula. If left untreated, this can affect&#xD;
      central vision. The current standard treatment for diabetic macular edema includes&#xD;
      medications injected directly into the eye (intravitreal injections) and laser eye treatment.&#xD;
      The drugs that are injected directly into the eye are known as anti-Vascular Endothelial&#xD;
      Growth Factor (anti-VEGF) agents which help to reduce the leaking. This includes bevacizumab&#xD;
      (Avastin®) and ranibizumab (Lucentis®).&#xD;
&#xD;
      However, some patients do not respond well to these anti-VEGF treatments will be given the&#xD;
      option of switching to an another class of medications, called steroids. Triamcinolone&#xD;
      acetonide is one of these steroids and is also injected directly into the eye. These steroids&#xD;
      will help reduce inflammation and possibly as a consequence, reduce swelling in the eye.&#xD;
&#xD;
      The purpose of this study is to determine what cellular factors affect a patient's treatment&#xD;
      response (amount of swelling reduction) following triamcinolone acetonide intravitreal&#xD;
      injections for diabetic macular edema.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cytokine levels (picograms per mL) between baseline triamcinolone acetonide injection and 3 months</measure>
    <time_frame>3 months after baseline triamcinolone acetonide injection</time_frame>
    <description>The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cytokine levels (picograms per mL) 3 months after 2nd triamcinolone acetonide injection</measure>
    <time_frame>3 months after 2nd triamcinolone acetonide injection</time_frame>
    <description>Note that the 2nd triamcinolone acetonide injection occurs 3 months after baseline injection. The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment</measure>
    <time_frame>3 months after baseline injection</time_frame>
    <description>The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in ETDRS BCVA is in ETDRS letters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment</measure>
    <time_frame>3 months after 2nd triamcinolone acetonide injection</time_frame>
    <description>The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in ETDRS BCVA is in ETDRS letters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography</measure>
    <time_frame>3 months after baseline injection</time_frame>
    <description>The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in CMT is in micrometers (um).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography</measure>
    <time_frame>3 months after 2nd triamcinolone acetonide injection</time_frame>
    <description>The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in CMT is in micrometers (um).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Triamcinolone Acetonide Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Triamcinolone Acetonide Injectable Suspension 40 mg/mL intravitreal injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Acetonide</intervention_name>
    <arm_group_label>Triamcinolone Acetonide Treatment</arm_group_label>
    <other_name>Triesence</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of Non Proliferative Diabetic Retinopathy (NDPR) or Proliferative Diabetic&#xD;
             Retinopathy as confirmed by IntraVenous Fluorescein Angiography (IVFA)&#xD;
&#xD;
          -  Prior treatment with ≥ 6 intravitreal anti-VEGF injections but no treatment in last 4&#xD;
             weeks&#xD;
&#xD;
          -  Less than 10% improvement in Central Macular Thickness on OCT scan and less than 1&#xD;
             line improvement in vision from baseline&#xD;
&#xD;
          -  Less than 10% reduction in macular volume&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Subjects with Type I or II diabetes mellitus&#xD;
&#xD;
          -  snellen Acuity 20/40 to 20/400 and its ETDRS equivalent&#xD;
&#xD;
          -  Ability to provide signed informed consent&#xD;
&#xD;
          -  Capable of complying with study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous intraocular injection of steroid medication.&#xD;
&#xD;
          -  Concurrent ocular disease (wet Age-Related Macular Degeneration, significant&#xD;
             Epiretinal Membrane, vitreomacular traction etc) that would limit visual acuity in the&#xD;
             opinion of the treating physician&#xD;
&#xD;
          -  Proliferative diabetic retinopathy in the study eye or PanRetinal Photocoagulation&#xD;
             within the last 12 months&#xD;
&#xD;
          -  Poor glycemic control HbA1c &gt;9%&#xD;
&#xD;
          -  Prior vitrectomy surgery.&#xD;
&#xD;
          -  Prior intraocular surgery within 3 months in study eye&#xD;
&#xD;
          -  Laser treatment within 3 months of study eye&#xD;
&#xD;
          -  Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or&#xD;
             extensive dermal) within 1 month prior to study enrollment.&#xD;
&#xD;
          -  Known history of Intraocular Pressure (IOP) elevation in response to steroid treatment&#xD;
             in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in&#xD;
             response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more&#xD;
             anti-glaucoma medications to keep IOP below 21 mm Hg.&#xD;
&#xD;
          -  Known allergies to study drug or fluorescein&#xD;
&#xD;
          -  History of stroke or acute Myocardial Infarction within 6 months of enrolment&#xD;
&#xD;
          -  Patients receiving dialysis for renal failure&#xD;
&#xD;
          -  Patients currently on systemic immunosuppression&#xD;
&#xD;
          -  Patients with glaucoma&#xD;
&#xD;
          -  Patients who are pregnant.&#xD;
&#xD;
          -  Unwilling or unable to follow or comply with all study related procedures&#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>Rajeev Muni, MD MSc FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael's Hospital Eye Clinic</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Macular Edema</keyword>
  <keyword>Ocular Cytokines</keyword>
  <keyword>Triamcinolone Acetonide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Triamcinolone diacetate</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/NCT02221453
org study id: PersDMEcytokineTA
nct id: NCT02221453
lead sponsor: 
has dmc: No
Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.
      The retina is like the film of a camera and is located in the back of the eye. This condition
      can develop in diabetics where swelling results from leaking of fluid from the blood vessels
      of the eye, into the center of the retina, the macula. If left untreated, this can affect
      central vision. The current standard treatment for diabetic macular edema includes
      medications injected directly into the eye (intravitreal injections) and laser eye treatment.
      The drugs that are injected directly into the eye are known as anti-Vascular Endothelial
      Growth Factor (anti-VEGF) agents which help to reduce the leaking. This includes bevacizumab
      (Avastin®) and ranibizumab (Lucentis®).

      However, some patients do not respond well to these anti-VEGF treatments will be given the
      option of switching to an another class of medications, called steroids. Triamcinolone
      acetonide is one of these steroids and is also injected directly into the eye. These steroids
      will help reduce inflammation and possibly as a consequence, reduce swelling in the eye.

      The purpose of this study is to determine what cellular factors affect a patient's treatment
      response (amount of swelling reduction) following triamcinolone acetonide intravitreal
      injections for diabetic macular edema.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in cytokine levels (picograms per mL) between baseline triamcinolone acetonide injection and 3 months
time frame: 3 months after baseline triamcinolone acetonide injection
description: The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
measure: Change in cytokine levels (picograms per mL) 3 months after 2nd triamcinolone acetonide injection
time frame: 3 months after 2nd triamcinolone acetonide injection
description: Note that the 2nd triamcinolone acetonide injection occurs 3 months after baseline injection. The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
measure: Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment
time frame: 3 months after baseline injection
description: The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in ETDRS BCVA is in ETDRS letters.
measure: Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment
time frame: 3 months after 2nd triamcinolone acetonide injection
description: The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in ETDRS BCVA is in ETDRS letters.
measure: Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography
time frame: 3 months after baseline injection
description: The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in CMT is in micrometers (um).
measure: Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography
time frame: 3 months after 2nd triamcinolone acetonide injection
description: The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in CMT is in micrometers (um).
arm group label: Triamcinolone Acetonide Treatment
arm group type: Other
description: Triamcinolone Acetonide Injectable Suspension 40 mg/mL intravitreal injection
intervention type: Drug
intervention name: Triamcinolone Acetonide
arm group label: Triamcinolone Acetonide Treatment
other name: Triesence
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rajeev Muni, MD MSc FRCSC
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Triamcinolone diacetate