<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/NCT04505618</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00276904</org_study_id>
    <secondary_id>R01EY030564</secondary_id>
    <nct_id>NCT04505618</nct_id>
  </id_info>
  <brief_title>Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease</brief_title>
  <acronym>OCTA-RVD</acronym>
  <official_title>Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will perform a prospective, longitudinal analysis of clinical and imaging findings&#xD;
      from normal controls and subjects with retinal vascular disease to better define the&#xD;
      diagnostic imaging criteria that signify change in disease stage. This includes disease&#xD;
      progression in early stages of disease or disease regression with appropriate&#xD;
      standard-of-care treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to perform a prospective, longitudinal analysis of clinical&#xD;
      and imaging findings from normal controls and subjects with retinal vascular disease to&#xD;
      better define the diagnostic imaging criteria that signify change in disease stage. This&#xD;
      includes disease progression in early stages of disease or disease regression with&#xD;
      appropriate standard-of-care treatment.&#xD;
&#xD;
      Subjects will be identified from healthy subjects (seen for screening eye exams) and diseased&#xD;
      subjects undergoing standard-of-care treatment or screening at eye clinic locations. The&#xD;
      study population will include subjects with retinal vascular disease including but not&#xD;
      limited to diabetic retinopathy, hypertension, retinal vein/arterial occlusion, and macular&#xD;
      degeneration. Subjects who are enrolled will undergo non-invasive, minimal risk, FDA approved&#xD;
      diagnostic imaging procedures to identify vascular changes.&#xD;
&#xD;
      The study methods will include retrospective review and collection of clinically approved&#xD;
      imaging data that is obtained through standard-of-care methods for subjects who meet&#xD;
      inclusion and exclusion criteria. Subjects who are identified in this manner will be asked to&#xD;
      participate in a prospective study by each clinical study site.&#xD;
&#xD;
      The study end-points include the correlation of diagnostic imaging findings from OCT based&#xD;
      images with fundus photographs, clinical disease stage and visual acuity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of Imaging</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1050</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <condition>Retinal Vein Occlusion</condition>
  <condition>Hypertension,Essential</condition>
  <condition>Retinal Vascular Disorder</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetics with and without Diabetic Retinopathy Only</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypertension Only</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetics w/ or w/o Diabetic Retinopathy &amp; Hypertension</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Swept-Source OCT Angiography</intervention_name>
    <description>Non-invasive, minimal risk, ocular imaging study</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Diabetics w/ or w/o Diabetic Retinopathy &amp; Hypertension</arm_group_label>
    <arm_group_label>Diabetics with and without Diabetic Retinopathy Only</arm_group_label>
    <arm_group_label>Hypertension Only</arm_group_label>
    <other_name>SS-OCTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spectral-Domain OCT Angiography</intervention_name>
    <description>Non-invasive, minimal risk, ocular imaging study</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Diabetics w/ or w/o Diabetic Retinopathy &amp; Hypertension</arm_group_label>
    <arm_group_label>Diabetics with and without Diabetic Retinopathy Only</arm_group_label>
    <arm_group_label>Hypertension Only</arm_group_label>
    <other_name>SD_OCTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fundus Imaging</intervention_name>
    <description>Non-invasive, minimal risk, ocular imaging study</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Diabetics w/ or w/o Diabetic Retinopathy &amp; Hypertension</arm_group_label>
    <arm_group_label>Diabetics with and without Diabetic Retinopathy Only</arm_group_label>
    <arm_group_label>Hypertension Only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Axial Length Measurement Device</intervention_name>
    <description>Non-invasive, minimal risk, ocular imaging study</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Diabetics w/ or w/o Diabetic Retinopathy &amp; Hypertension</arm_group_label>
    <arm_group_label>Diabetics with and without Diabetic Retinopathy Only</arm_group_label>
    <arm_group_label>Hypertension Only</arm_group_label>
    <other_name>IOL Master</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Both subjects with diseases and controls:&#xD;
&#xD;
          -  Children (age&lt;18)&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Developmentally delayed subjects&#xD;
&#xD;
          -  Subjects unable to provide informed consent&#xD;
&#xD;
          -  Inability to cooperate with tests and study instructions&#xD;
&#xD;
          -  Images with motion artifact or signal strength &lt; 7&#xD;
&#xD;
          -  History of glaucoma&#xD;
&#xD;
          -  History of age-related macular degeneration&#xD;
&#xD;
          -  History of any visually significant eye disease&#xD;
&#xD;
          -  History of proliferative diabetic retinopathy&#xD;
&#xD;
          -  History of any inflammatory disease&#xD;
&#xD;
          -  History of heart disease&#xD;
&#xD;
          -  History of thyroid disease.&#xD;
&#xD;
          -  Additional criteria for controls:&#xD;
&#xD;
          -  History of any type of Diabetes Mellitus&#xD;
&#xD;
          -  History of any type of Hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Amir H Kashani, MD, PhD</last_name>
    <phone>410-502-2789</phone>
    <email>akashan1@jhmi.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ana C Martinez, MPH</last_name>
    <phone>410-502-2789</phone>
    <email>acollaz5@jhmi.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>June Hall</last_name>
      <phone>410-502-2789</phone>
      <email>jhall81@jhmi.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ana C Martinez</last_name>
      <email>acollaz5@jhmi.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Amir H Kashani, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_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/NCT04505618
org study id: IRB00276904
secondary id: R01EY030564
nct id: NCT04505618
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study will perform a prospective, longitudinal analysis of clinical and imaging findings
      from normal controls and subjects with retinal vascular disease to better define the
      diagnostic imaging criteria that signify change in disease stage. This includes disease
      progression in early stages of disease or disease regression with appropriate
      standard-of-care treatment.
The objective of this study is to perform a prospective, longitudinal analysis of clinical
      and imaging findings from normal controls and subjects with retinal vascular disease to
      better define the diagnostic imaging criteria that signify change in disease stage. This
      includes disease progression in early stages of disease or disease regression with
      appropriate standard-of-care treatment.

      Subjects will be identified from healthy subjects (seen for screening eye exams) and diseased
      subjects undergoing standard-of-care treatment or screening at eye clinic locations. The
      study population will include subjects with retinal vascular disease including but not
      limited to diabetic retinopathy, hypertension, retinal vein/arterial occlusion, and macular
      degeneration. Subjects who are enrolled will undergo non-invasive, minimal risk, FDA approved
      diagnostic imaging procedures to identify vascular changes.

      The study methods will include retrospective review and collection of clinically approved
      imaging data that is obtained through standard-of-care methods for subjects who meet
      inclusion and exclusion criteria. Subjects who are identified in this manner will be asked to
      participate in a prospective study by each clinical study site.

      The study end-points include the correlation of diagnostic imaging findings from OCT based
      images with fundus photographs, clinical disease stage and visual acuity.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Correlation of Imaging
time frame: 5 years
description: Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage
arm group label: Controls
arm group type: Other
description: Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.
arm group label: Diabetics with and without Diabetic Retinopathy Only
arm group type: Other
description: Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
arm group label: Hypertension Only
arm group type: Other
description: Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
arm group label: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
arm group type: Other
description: Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
intervention type: Device
intervention name: Swept-Source OCT Angiography
description: Non-invasive, minimal risk, ocular imaging study
arm group label: Controls
arm group label: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
arm group label: Diabetics with and without Diabetic Retinopathy Only
arm group label: Hypertension Only
other name: SS-OCTA
intervention type: Device
intervention name: Spectral-Domain OCT Angiography
description: Non-invasive, minimal risk, ocular imaging study
arm group label: Controls
arm group label: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
arm group label: Diabetics with and without Diabetic Retinopathy Only
arm group label: Hypertension Only
other name: SD_OCTA
intervention type: Device
intervention name: Fundus Imaging
description: Non-invasive, minimal risk, ocular imaging study
arm group label: Controls
arm group label: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
arm group label: Diabetics with and without Diabetic Retinopathy Only
arm group label: Hypertension Only
intervention type: Device
intervention name: Axial Length Measurement Device
description: Non-invasive, minimal risk, ocular imaging study
arm group label: Controls
arm group label: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
arm group label: Diabetics with and without Diabetic Retinopathy Only
arm group label: Hypertension Only
other name: IOL Master
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amir H Kashani, MD, PhD
phone: 410-502-2789
email: akashan1@jhmi.edu
last name: Ana C Martinez, MPH
phone: 410-502-2789
email: acollaz5@jhmi.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Retinopathy
mesh term: Retinal Vein Occlusion
mesh term: Vascular Diseases
mesh term: Essential Hypertension