<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/NCT03765112</url>
  </required_header>
  <id_info>
    <org_study_id>H18-02095</org_study_id>
    <nct_id>NCT03765112</nct_id>
  </id_info>
  <brief_title>Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT</brief_title>
  <official_title>Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates micro-vascular changes in patients with diabetes. Results of diseased&#xD;
      retinas will be compared to healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the&#xD;
      most prevalent complication of DM and a leading cause of visual impairment due to closure of&#xD;
      capillaries. High-resolution imaging techniques of the retina and its supplying vascular&#xD;
      networks can allow novel insight to subtle changes that cannot be appreciated in standard&#xD;
      fundus examination. In this study capillary changes of patients with different severity&#xD;
      levels of diabetic retinopathy will be investigated with non-invasive imaging technology to&#xD;
      better understand the process of disease progression.&#xD;
&#xD;
      Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral&#xD;
      domain OCT and ultra wide-field imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perfusion density</measure>
    <time_frame>6 months</time_frame>
    <description>The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Areas of different perfusion density</measure>
    <time_frame>6 months</time_frame>
    <description>Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foveal avascular zone (FAZ)</measure>
    <time_frame>6 months</time_frame>
    <description>Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foveal avascular zone (FAZ)</measure>
    <time_frame>6 months</time_frame>
    <description>The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of predominantly peripheral lesions (PPL)</measure>
    <time_frame>6 months</time_frame>
    <description>The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal layer thickness</measure>
    <time_frame>6 months</time_frame>
    <description>Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year</measure>
    <time_frame>18 months</time_frame>
    <description>Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">175</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>OCTA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical coherence tomography angiography</intervention_name>
    <description>Multiple scans of the retina will be recorded to evaluate microvascular changes.</description>
    <arm_group_label>OCTA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 Participants can have 1 or 2 study eyes&#xD;
&#xD;
        Patient Group:&#xD;
&#xD;
          -  Diabetes mellitus type 1 or 2&#xD;
&#xD;
          -  Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substantial media opacities that would preclude successful imaging&#xD;
&#xD;
               -  Active intraocular inflammation (grade trace or above) in either eye like&#xD;
                  infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as&#xD;
                  idiopathic or autoimmune-associated uveitis in either eye&#xD;
&#xD;
               -  Structural damage to the center of macula in the study eye&#xD;
&#xD;
               -  History of prior panretinal photocoagulation&#xD;
&#xD;
               -  History of treatment with intravitreal agents over the prior 6 months&#xD;
&#xD;
               -  Macular edema involving the central subfield&#xD;
&#xD;
               -  Prior history of vitrectomy&#xD;
&#xD;
               -  Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within&#xD;
                  foveal avascular zone (FAZ) or organized hard exudate plaques&#xD;
&#xD;
               -  Substantial non-diabetic intraocular pathology in the study eye including retinal&#xD;
                  vascular occlusion, retinal detachment, macular hole, choroidal&#xD;
                  neovascularization, macula dystrophies&#xD;
&#xD;
               -  Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the&#xD;
                  study eye within 3 months preceding Day 0, or history of corneal transplantation&#xD;
                  in the study eye&#xD;
&#xD;
               -  Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg&#xD;
                  despite treatment with anti-glaucoma medication)or history of glaucoma filtration&#xD;
                  surgery&#xD;
&#xD;
               -  Inability to obtain fundus images of sufficient quality to be analyzed and graded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eduardo Navajas, MD</last_name>
    <phone>604 875 5475</phone>
    <email>edunavajas@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Theresa Wiens</last_name>
    <phone>604-875-4111</phone>
    <phone_ext>62544</phone_ext>
    <email>twiens@eyecarecentre.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Eye Care Center</name>
      <address>
        <city>Vancouver</city>
        <zip>V5Z 3N9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eduardo Navajas, MD</last_name>
      <phone>604 875 5475</phone>
      <email>edunavajas@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Theresa Wiens, MSc</last_name>
      <phone>604-875-4111</phone>
      <phone_ext>62544</phone_ext>
      <email>twiens@eyecarecentre.org</email>
    </contact_backup>
    <investigator>
      <last_name>Sonja Karst, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Eduardo Navajas</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03765112
org study id: H18-02095
nct id: NCT03765112
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased
      retinas will be compared to healthy controls.
The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the
      most prevalent complication of DM and a leading cause of visual impairment due to closure of
      capillaries. High-resolution imaging techniques of the retina and its supplying vascular
      networks can allow novel insight to subtle changes that cannot be appreciated in standard
      fundus examination. In this study capillary changes of patients with different severity
      levels of diabetic retinopathy will be investigated with non-invasive imaging technology to
      better understand the process of disease progression.

      Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral
      domain OCT and ultra wide-field imaging.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Perfusion density
time frame: 6 months
description: The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
measure: Areas of different perfusion density
time frame: 6 months
description: Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient
measure: Foveal avascular zone (FAZ)
time frame: 6 months
description: Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
measure: Foveal avascular zone (FAZ)
time frame: 6 months
description: The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
measure: Presence of predominantly peripheral lesions (PPL)
time frame: 6 months
description: The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA
measure: Retinal layer thickness
time frame: 6 months
description: Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA
measure: Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year
time frame: 18 months
description: Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,
arm group label: OCTA
arm group type: Experimental
description: Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.
intervention type: Device
intervention name: Optical coherence tomography angiography
description: Multiple scans of the retina will be recorded to evaluate microvascular changes.
arm group label: OCTA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eduardo Navajas, MD
phone: 604 875 5475
email: edunavajas@gmail.com
last name: Theresa Wiens
phone: 604-875-4111
phone ext: 62544
email: twiens@eyecarecentre.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Eduardo Navajas
investigator title: Principal Investigator
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
sharing ipd: No