<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/NCT04469140</url>
  </required_header>
  <id_info>
    <org_study_id>BIRC-02 IMPACT SWAGGER</org_study_id>
    <nct_id>NCT04469140</nct_id>
  </id_info>
  <brief_title>Non Exudative AMD Imaged With SS-OCT- Extension</brief_title>
  <acronym>BIRC-02</acronym>
  <official_title>Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Image Reading Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Image Reading Center</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators wish to better understand the role of the choriocapillaris (CC) in the&#xD;
      formation and progression of non-exudative in age related macular degeneration (armd) by&#xD;
      imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by&#xD;
      studying their inter-dependence to determine if the loss of the CC could prove useful as an&#xD;
      anatomic clinical trial endpoint in future drug trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators wish to better understand the role of the choriocapillaris (CC) in the&#xD;
      formation and progression of non-exudative in age related macular degeneration (armd) by&#xD;
      imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by&#xD;
      studying their inter-dependence to determine if the loss of the CC could prove useful as an&#xD;
      anatomic clinical trial endpoint in future drug trials. This is an extension of a currently&#xD;
      ongoing longitudinal observational study (BIRC-01) (NCT03688243).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 18, 2020</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline</measure>
    <time_frame>1-year and 2-year time points</time_frame>
    <description>Compare the percentage of choroidal perfusion deficits as measured using automated algorithms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-existing and new sub-clinical Macular Neovascularization (MNV)</measure>
    <time_frame>1-year and 2-year time points</time_frame>
    <description>Identify the number of abnormal new vessels arising from the Choroid at Baseline, 1-year and 2-year time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Automated Drusen Volume measurements</measure>
    <time_frame>1-year and 2-year time points</time_frame>
    <description>Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Automated Geography Atrophy measurements</measure>
    <time_frame>1-year and 2-year time points</time_frame>
    <description>Compare the automated measurements of Geography Atrophy area using the Zeiss algorithm with manual measurements by trained readers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Choroidal Thickness (millimeters)</measure>
    <time_frame>1-year and 2-year time points</time_frame>
    <description>Correlate Choroidal Thickness measurements (millimeters) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Choroidal Vascularity Index (percentage)</measure>
    <time_frame>1-year and 2-year time points</time_frame>
    <description>Correlate Choroidal Vascularity Index (percentage) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Dry Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Cohort 1 'IMPACT Cohort'</arm_group_label>
    <description>Subjects with intermediate AMD in both eyes, and at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR subjects with AMD (early or intermediate) diagnosed in one eye and exudative AMD diagnosed in the fellow eye will undergo SS-OCT imaging every 3 months for 2 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 'SWAGGER Cohort'</arm_group_label>
    <description>Subjects with GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye will undergo SS-OCT imaging every 3 months for 2 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <description>Subjects with GA enrolled in another trial</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SS-OCT imaging</intervention_name>
    <description>All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument</description>
    <arm_group_label>Cohort 1 'IMPACT Cohort'</arm_group_label>
    <arm_group_label>Cohort 2 'SWAGGER Cohort'</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <other_name>Zeiss PlexElite</other_name>
    <other_name>PlexElite 9000</other_name>
    <other_name>Swept Source OCT</other_name>
    <other_name>Optical Coherence Tomography Angiography</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      At baseline or follow up, an optional blood sample for future exploratory genetics analysis&#xD;
      will be collected if not already collected during the BIRC-01 study&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy and who&#xD;
        have completed the BIRC-01 study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrollment in and completion of the BIRC-01 study&#xD;
&#xD;
          -  Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the&#xD;
             central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or&#xD;
             nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or&#xD;
             early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD&#xD;
             in the other eye OR clinical diagnosis of GA or nGA secondary to AMD that is at least&#xD;
             the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7&#xD;
             disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF&#xD;
             agents&#xD;
&#xD;
          -  Willing and able to comply with clinic visits and study-related procedures&#xD;
&#xD;
          -  Provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with exudative AMD in both eyes&#xD;
&#xD;
          -  Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.&#xD;
&#xD;
          -  Presence of confounding ocular diagnosis such as myopia &gt;6D, or other ocular&#xD;
             conditions that may cause retinal pigment epithelium atrophy or exudative MNV&#xD;
&#xD;
          -  Subjects currently or previously enrolled in other interventional clinical trials in&#xD;
             which treatment was administered to the study eye.&#xD;
&#xD;
          -  Previous vitrectomy or intravitreal injections in the study eye.&#xD;
&#xD;
          -  Axial length measurement ≥ 26 mm.&#xD;
&#xD;
          -  Subjects unable to give informed consent.&#xD;
&#xD;
          -  Subjects who are unable to comply with imaging guidelines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadia Waheed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Image Reading Center/Tufts Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philip Rosenfield, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bascom Palmer Eye Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jen Tourtellot</last_name>
    <phone>1-855-535-BIRC (2472)</phone>
    <email>admin@bostonimagereadingcenter.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California Los Angeles Doheny Eye Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janett Mendez</last_name>
    </contact>
    <investigator>
      <last_name>SriniVas Sadda, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bascom Palmer Eye Institue</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monica Arango</last_name>
    </contact>
    <investigator>
      <last_name>Philip J Rosenfeld, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New England Eye Center/Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nancy Gee, MPH</last_name>
    </contact>
    <investigator>
      <last_name>Michelle Liang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vitreous Retina Macular Consultants of NY</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renata Salgado</last_name>
    </contact>
    <investigator>
      <last_name>Bailey Freund, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Melbourne University CERA</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Caruso</last_name>
    </contact>
    <investigator>
      <last_name>Robyn Guymer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AMD</keyword>
  <keyword>Early AMD</keyword>
  <keyword>Intermediate AMD</keyword>
  <keyword>Geographic Atrophy</keyword>
  <keyword>Nascent GA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Geographic Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04469140
org study id: BIRC-02 IMPACT SWAGGER
nct id: NCT04469140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The investigators wish to better understand the role of the choriocapillaris (CC) in the
      formation and progression of non-exudative in age related macular degeneration (armd) by
      imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by
      studying their inter-dependence to determine if the loss of the CC could prove useful as an
      anatomic clinical trial endpoint in future drug trials.
The investigators wish to better understand the role of the choriocapillaris (CC) in the
      formation and progression of non-exudative in age related macular degeneration (armd) by
      imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by
      studying their inter-dependence to determine if the loss of the CC could prove useful as an
      anatomic clinical trial endpoint in future drug trials. This is an extension of a currently
      ongoing longitudinal observational study (BIRC-01) (NCT03688243).
observational model: Cohort
time perspective: Prospective
measure: Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline
time frame: 1-year and 2-year time points
description: Compare the percentage of choroidal perfusion deficits as measured using automated algorithms
measure: Pre-existing and new sub-clinical Macular Neovascularization (MNV)
time frame: 1-year and 2-year time points
description: Identify the number of abnormal new vessels arising from the Choroid at Baseline, 1-year and 2-year time points
measure: Automated Drusen Volume measurements
time frame: 1-year and 2-year time points
description: Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers
measure: Automated Geography Atrophy measurements
time frame: 1-year and 2-year time points
description: Compare the automated measurements of Geography Atrophy area using the Zeiss algorithm with manual measurements by trained readers
measure: Choroidal Thickness (millimeters)
time frame: 1-year and 2-year time points
description: Correlate Choroidal Thickness measurements (millimeters) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates
measure: Choroidal Vascularity Index (percentage)
time frame: 1-year and 2-year time points
description: Correlate Choroidal Vascularity Index (percentage) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates
arm group label: Cohort 1 'IMPACT Cohort'
description: Subjects with intermediate AMD in both eyes, and at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR subjects with AMD (early or intermediate) diagnosed in one eye and exudative AMD diagnosed in the fellow eye will undergo SS-OCT imaging every 3 months for 2 years
arm group label: Cohort 2 'SWAGGER Cohort'
description: Subjects with GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye will undergo SS-OCT imaging every 3 months for 2 years
arm group label: Cohort 3
description: Subjects with GA enrolled in another trial
intervention type: Device
intervention name: SS-OCT imaging
description: All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
arm group label: Cohort 1 'IMPACT Cohort'
arm group label: Cohort 2 'SWAGGER Cohort'
arm group label: Cohort 3
other name: Zeiss PlexElite
other name: PlexElite 9000
other name: Swept Source OCT
other name: Optical Coherence Tomography Angiography
At baseline or follow up, an optional blood sample for future exploratory genetics analysis
      will be collected if not already collected during the BIRC-01 study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nadia Waheed, MD
role: Principal Investigator
affiliation: Boston Image Reading Center/Tufts Medical Center
last name: Philip Rosenfield, MD, PhD
role: Principal Investigator
affiliation: Bascom Palmer Eye Institute
last name: Jen Tourtellot
phone: 1-855-535-BIRC (2472)
email: admin@bostonimagereadingcenter.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Australia
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Geographic Atrophy
sharing ipd: Undecided