<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/NCT02253030</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#000010535</org_study_id>
    <nct_id>NCT02253030</nct_id>
  </id_info>
  <brief_title>OCT Angiography in Wet AMD</brief_title>
  <official_title>Optical Coherence Tomography Angiography in Neovascular Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <brief_summary>
    <textblock>
      The primary goals of this study are to use optical coherence tomography (OCT) angiography&#xD;
      (blood vessel mapping) to:&#xD;
&#xD;
        1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)&#xD;
&#xD;
        2. evaluate patients undergoing treatment for wet AMD&#xD;
&#xD;
        3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of choroidal neovascular (CNV) vessel area in mm2</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of CNV membrane area in mm2</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of CNV length density in mm</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of retinal fluid volume in mm3</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of drusen area in mm2</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Neovascular (Wet) Age-related Macular Degeneration (AMD)</condition>
  <arm_group>
    <arm_group_label>Newly-diagnosed, untreated wet AMD</arm_group_label>
    <description>This group will be adults newly diagnosed with wet AMD who have not undergone any treatment for the condition. Their data will be gathered only once, prior to treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wet AMD undergoing &quot;as-needed&quot; treatment</arm_group_label>
    <description>This group will be adults undergoing treatment as-needed for wet AMD. They will be followed monthly over the course of 1 year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-risk eyes</arm_group_label>
    <description>This group will be adults with wet AMD in one eye and findings of dry AMD in the other. The eye with dry AMD will be followed every 6 months for 3 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wet AMD undergoing a &quot;treat and extend&quot; strategy</arm_group_label>
    <description>This group will be adults with wet AMD undergoing treatment under the &quot;treat and extend&quot; strategy. (The &quot;treat and extend&quot; strategy increases the intervals between treatments as long as the macula remains dry.) They will be followed over the course of 1 year with extra imaging before extending follow-up intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical Coherence Tomography</intervention_name>
    <arm_group_label>High-risk eyes</arm_group_label>
    <arm_group_label>Newly-diagnosed, untreated wet AMD</arm_group_label>
    <arm_group_label>Wet AMD undergoing &quot;as-needed&quot; treatment</arm_group_label>
    <arm_group_label>Wet AMD undergoing a &quot;treat and extend&quot; strategy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Both female and male participants over the age of 50 are being studied.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (Groups with wet AMD):&#xD;
&#xD;
          -  Adults aged 50 and older with clinical findings of treatment-naïve (never treated)&#xD;
             neovascular AMD with active new blood vessel growth confirmed by clinical testing will&#xD;
             be considered&#xD;
&#xD;
        Inclusion Criteria (Group with healthy eyes)&#xD;
&#xD;
          -  No evidence of retinal disease&#xD;
&#xD;
          -  Refractive error greater than +3.00 diopters or -7.00 diopters (glasses Rx)&#xD;
&#xD;
          -  No recent eye surgery in the last 4 months&#xD;
&#xD;
          -  No significant cataract to interfere with the quality of the imaging&#xD;
&#xD;
        Exclusion Criteria (All Groups):&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Significant kidney disease&#xD;
&#xD;
          -  Blood pressure greater than 180/110&#xD;
&#xD;
          -  Previous macular laser treatment&#xD;
&#xD;
          -  Inability to maintain stable fixation during OCT imaging&#xD;
&#xD;
          -  Visual acuity worse than 20/200&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Bailey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>George Pacheco, COA</last_name>
    <phone>503-494-7398</phone>
    <email>pachecge@ohsu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Denny Romfh, OD</last_name>
    <phone>503-494-4351</phone>
    <email>romfhd@ohsu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Casey Eye Institute, Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>George Pacheco, COA</last_name>
      <phone>503-494-7398</phone>
      <email>pachecge@ohsu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Denny Romfh, OD</last_name>
      <phone>503-494-4351</phone>
      <email>romfhd@ohsu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Christina Flaxel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Hwang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Klein, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Phoebe Lin, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andreas Lauer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kavita Bhavsar, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Campbell, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yali Jia, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ou Tan, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>David Huang</investigator_full_name>
    <investigator_title>Steven Bailey, MD, Assistant Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>AMD</keyword>
  <keyword>OCT</keyword>
  <keyword>Angiography</keyword>
  <keyword>Macular degeneration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</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/NCT02253030
org study id: IRB#000010535
nct id: NCT02253030
lead sponsor: 
The primary goals of this study are to use optical coherence tomography (OCT) angiography
      (blood vessel mapping) to:

        1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)

        2. evaluate patients undergoing treatment for wet AMD

        3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.
observational model: Case-Control
time perspective: Prospective
measure: Measure of choroidal neovascular (CNV) vessel area in mm2
time frame: 1 year
measure: Measure of CNV membrane area in mm2
time frame: 1 year
measure: Measure of CNV length density in mm
time frame: 1 year
measure: Measure of retinal fluid volume in mm3
time frame: 1 year
measure: Measure of drusen area in mm2
time frame: 3 years
arm group label: Newly-diagnosed, untreated wet AMD
description: This group will be adults newly diagnosed with wet AMD who have not undergone any treatment for the condition. Their data will be gathered only once, prior to treatment.
arm group label: Wet AMD undergoing "as-needed" treatment
description: This group will be adults undergoing treatment as-needed for wet AMD. They will be followed monthly over the course of 1 year.
arm group label: High-risk eyes
description: This group will be adults with wet AMD in one eye and findings of dry AMD in the other. The eye with dry AMD will be followed every 6 months for 3 years.
arm group label: Wet AMD undergoing a "treat and extend" strategy
description: This group will be adults with wet AMD undergoing treatment under the "treat and extend" strategy. (The "treat and extend" strategy increases the intervals between treatments as long as the macula remains dry.) They will be followed over the course of 1 year with extra imaging before extending follow-up intervals.
intervention type: Device
intervention name: Optical Coherence Tomography
arm group label: High-risk eyes
arm group label: Newly-diagnosed, untreated wet AMD
arm group label: Wet AMD undergoing "as-needed" treatment
arm group label: Wet AMD undergoing a "treat and extend" strategy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven Bailey, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: George Pacheco, COA
phone: 503-494-7398
email: pachecge@ohsu.edu
last name: Denny Romfh, OD
phone: 503-494-4351
email: romfhd@ohsu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: David Huang
investigator title: Steven Bailey, MD, Assistant Professor of Ophthalmology
mesh term: Macular Degeneration