<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/NCT01712841</url>
  </required_header>
  <id_info>
    <org_study_id>OHSU IRB #00008749</org_study_id>
    <nct_id>NCT01712841</nct_id>
  </id_info>
  <brief_title>Non-exudative Age-related Macular Degeneration</brief_title>
  <acronym>NEAMD</acronym>
  <official_title>A Prospective Study Examining Patients With Non-exudative Age-related Macular Degeneration (NEAMD) of Different Severity</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>
      Age-related macular degeneration (AMD) is the most prevalent cause of vision loss in&#xD;
      developed countries and is often discussed in terms of the &quot;dry&quot; and the &quot;wet&quot; forms. The&#xD;
      &quot;wet&quot; form of AMD is the more advanced form of the disease and is responsible for 80% of the&#xD;
      legal blindness in AMD. Treatment options include a promising class of biologics called&#xD;
      anti-vascular endothelial growth factors, as well as photodynamic therapy and laser surgery.&#xD;
      These therapies can slow further vision loss, but cannot achieve recovery of lost vision. The&#xD;
      &quot;wet&quot; form of AMD is always preceded by the &quot;dry&quot; form. Therefore, it is reasonable to expect&#xD;
      that the early detection and treatment of the &quot;dry&quot; form may help reduce vision loss or&#xD;
      progression to the more damaging &quot;wet&quot; form. Unfortunately, symptoms appear only in advanced&#xD;
      stages of the &quot;dry&quot; form. As light sensitive cells in the macula breakdown in a process&#xD;
      called geographic atrophy, the patient may notice blurred central vision.&#xD;
&#xD;
      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal&#xD;
      and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,&#xD;
      except that OCT measures the intensity of reflected light rather than acoustical waves.&#xD;
&#xD;
      This study aims is to use OCT technology to compare how the retinal anatomy and blood flow&#xD;
      differ within three severity groupings of non-exudative age-related macular degeneration&#xD;
      (NEAMD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">January 18, 2018</completion_date>
  <primary_completion_date type="Actual">January 18, 2018</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>Number of patients with severe NEAMD who have changes in retinal anatomy/blood flow compared with patients with mild and moderate NEAMD</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Non-exudative Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Severe NEAMD</arm_group_label>
    <description>Presence of definite central or noncentral geographic atrophy within 3000 microns of the foveal center</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate/Intermediate NEAMD</arm_group_label>
    <description>Presence of large drusen (&gt;125µ) and pigmentary changes without geographic atrophy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild/Early NEAMD</arm_group_label>
    <description>Presence of small or medium drusen without geographic atrophy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals between the ages of 60 and 85 years of age presenting to the Retina Service&#xD;
        within the Department of Ophthalmology at the Casey Eye Institute of Oregon Health &amp;&#xD;
        Science University with signs and symptoms of non-exudative AMD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of mild, moderate or severe NEAMD.&#xD;
&#xD;
          -  Media clarity, pupillary dilation, and subject cooperation sufficient for adequate&#xD;
             fundus photographs.&#xD;
&#xD;
          -  Vision better than 20/200&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent.&#xD;
&#xD;
          -  Inability to maintain stable fixation for OCT imaging.&#xD;
&#xD;
          -  A condition that, in the opinion of the investigator, would preclude participation in&#xD;
             the study (e.g. unstable medical status including blood pressure, cardiovascular&#xD;
             disease, and glycemic control).&#xD;
&#xD;
          -  A concurrent ocular pathology that may contribute to vision loss (e.g., CNV, glaucoma,&#xD;
             visually significant cataract, optic neuropathy, diabetic retinopathy, history of&#xD;
             retinal surgery) or interfere with acquisition of high-quality images&#xD;
&#xD;
          -  Blood pressure &gt; 180/110 (systolic above 180 OR diastolic above 110). If blood&#xD;
             pressure is brought below 180/110 by anti-hypertensive treatment, subject can become&#xD;
             eligible.&#xD;
&#xD;
          -  An ocular condition is present that, in the opinion of the investigator, might affect&#xD;
             or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis&#xD;
             or other ocular inflammatory disease, neovascular glaucoma, etc.).&#xD;
&#xD;
          -  Substantial cataract that, in the opinion of the investigator, is likely to be&#xD;
             decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity&#xD;
             to 20/40 or worse if eye was otherwise normal).&#xD;
&#xD;
          -  Unable to ambulate and take tram from clinic to where OCT is located&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas S Hwang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</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>Thomas S. Hwang, MD, Associate Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Dry AMD</keyword>
  <keyword>Age-related macular degeneration</keyword>
  <keyword>Optical coherenece tomography</keyword>
  <keyword>Imaging</keyword>
  <keyword>Blood flow</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>
  <!-- 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/NCT01712841
org study id: OHSU IRB #00008749
nct id: NCT01712841
lead sponsor: 
Age-related macular degeneration (AMD) is the most prevalent cause of vision loss in
      developed countries and is often discussed in terms of the "dry" and the "wet" forms. The
      "wet" form of AMD is the more advanced form of the disease and is responsible for 80% of the
      legal blindness in AMD. Treatment options include a promising class of biologics called
      anti-vascular endothelial growth factors, as well as photodynamic therapy and laser surgery.
      These therapies can slow further vision loss, but cannot achieve recovery of lost vision. The
      "wet" form of AMD is always preceded by the "dry" form. Therefore, it is reasonable to expect
      that the early detection and treatment of the "dry" form may help reduce vision loss or
      progression to the more damaging "wet" form. Unfortunately, symptoms appear only in advanced
      stages of the "dry" form. As light sensitive cells in the macula breakdown in a process
      called geographic atrophy, the patient may notice blurred central vision.

      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal
      and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,
      except that OCT measures the intensity of reflected light rather than acoustical waves.

      This study aims is to use OCT technology to compare how the retinal anatomy and blood flow
      differ within three severity groupings of non-exudative age-related macular degeneration
      (NEAMD).
observational model: Case-Control
time perspective: Prospective
measure: Number of patients with severe NEAMD who have changes in retinal anatomy/blood flow compared with patients with mild and moderate NEAMD
time frame: 1 year
arm group label: Severe NEAMD
description: Presence of definite central or noncentral geographic atrophy within 3000 microns of the foveal center
arm group label: Moderate/Intermediate NEAMD
description: Presence of large drusen (>125µ) and pigmentary changes without geographic atrophy
arm group label: Mild/Early NEAMD
description: Presence of small or medium drusen without geographic atrophy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Thomas S Hwang, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: David Huang
investigator title: Thomas S. Hwang, MD, Associate Professor of Ophthalmology
mesh term: Macular Degeneration
mesh term: Geographic Atrophy