<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/NCT04498000</url>
  </required_header>
  <id_info>
    <org_study_id>R1661/58/2019</org_study_id>
    <nct_id>NCT04498000</nct_id>
  </id_info>
  <brief_title>Analysis of the Pachychoroid Phenotype in an Asian Population</brief_title>
  <official_title>Analysis of the Pachychoroid Phenotype in an Asian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore National Eye Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Singapore National Eye Centre</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The understanding of pachychoroid phenotype is incomplete. It is important to understand the&#xD;
      risk of conversion from an uncomplicated pachychoroid phenotype to the pachychoroid disease&#xD;
      phenotype, to guide appropriate management of these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The progression of uncomplicated pachychoroid phenotype to pachychoroid disease is not well&#xD;
      established and the pathophysiology of these phenotypes remains unknown: specifically if the&#xD;
      occurence of pachyvessels is the primary event, or develops secondary to the inner choroidal&#xD;
      attenuation.&#xD;
&#xD;
      A longitudinal study of the pachychoroid phenotype will provide much needed information&#xD;
      regarding the natural history of the pachychoroid phenotype. Secondly, a detailed chronicle&#xD;
      of the choroidal alterations in the pachychoroid disease spectrum may yield insights into the&#xD;
      pathogenesis, and facilitate the development of disease modulation strategies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Incidence of progression of pachychoroid phenotypes in 2 subtypes</measure>
    <time_frame>2 years observation</time_frame>
    <description>Two subtypes of pachychoroid phenotypes:&#xD;
from an uncomplicated pachychoroid phenotype, to a pachychoroid disease entity&#xD;
from non neo-vascular pachychoroid disease, to neovascular pachychoroid disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk factors for progression in 2 subtypes of pachychoroid phenotypes</measure>
    <time_frame>2 years</time_frame>
    <description>from an uncomplicated pachychoroid phenotype, to a pachychoroidal disease entity&#xD;
from neo-vascular pachychoroid disease, to neovascular pachychoroid disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the chronology of choroidal changes in patients</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the occurence of pachyvessles is the primary event, or consequent to inner choroidal attenuation</description>
  </primary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pachychoroid Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study will recruit 120 participants from the Singapore National Eye Centre (SNEC) and&#xD;
        National University Hospital (NUH). SNEC will recruit 70 participants and NUH will recruit&#xD;
        50 participants for this study. There is no subject restriction based on race of the&#xD;
        subject.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Presence of uncomplicated and/or non-neovascular pachychoroid phenotype in at least&#xD;
             one eye.&#xD;
&#xD;
          2. Subfoveal choroidal thickness &gt;300 microns on enhanced depth imaging optical coherence&#xD;
             tomography for at least one eye&#xD;
&#xD;
          3. Male or female patients above 45 years of age&#xD;
&#xD;
          4. Willingness to undergo pupil dilation, and protocol- required procedures for both eyes&#xD;
&#xD;
          5. Willing to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of disorders of the ocular media which interfere with visual acuity and other&#xD;
             ocular assessments, including Spectral domain- optical coherence tomography during the&#xD;
             study period&#xD;
&#xD;
          2. Pregnant or nursing women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinyi Su, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gemmy Cheung, MBBS</last_name>
    <phone>+65 83828173</phone>
    <email>gemmy.cheung.c.m@singhealth.com.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kelvin Teo, MBBS</last_name>
    <phone>+65 98000002</phone>
    <email>kelvin.teo.y.c@singhealth.com.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinyi Su, MBBS</last_name>
      <email>xinyi_su@nuhs.edu.sg</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Singapore National Eye Centre</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Singapore National Eye Centre</investigator_affiliation>
    <investigator_full_name>Gemmy Cheung Chui Ming</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pachychoroid neovasculopathy</keyword>
  <keyword>pachychoroid choroidal vasculopathy</keyword>
  <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/NCT04498000
org study id: R1661/58/2019
nct id: NCT04498000
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The understanding of pachychoroid phenotype is incomplete. It is important to understand the
      risk of conversion from an uncomplicated pachychoroid phenotype to the pachychoroid disease
      phenotype, to guide appropriate management of these patients.
The progression of uncomplicated pachychoroid phenotype to pachychoroid disease is not well
      established and the pathophysiology of these phenotypes remains unknown: specifically if the
      occurence of pachyvessels is the primary event, or develops secondary to the inner choroidal
      attenuation.

      A longitudinal study of the pachychoroid phenotype will provide much needed information
      regarding the natural history of the pachychoroid phenotype. Secondly, a detailed chronicle
      of the choroidal alterations in the pachychoroid disease spectrum may yield insights into the
      pathogenesis, and facilitate the development of disease modulation strategies.
observational model: Cohort
time perspective: Prospective
measure: Incidence of progression of pachychoroid phenotypes in 2 subtypes
time frame: 2 years observation
description: Two subtypes of pachychoroid phenotypes:
from an uncomplicated pachychoroid phenotype, to a pachychoroid disease entity
from non neo-vascular pachychoroid disease, to neovascular pachychoroid disease
measure: Risk factors for progression in 2 subtypes of pachychoroid phenotypes
time frame: 2 years
description: from an uncomplicated pachychoroid phenotype, to a pachychoroidal disease entity
from neo-vascular pachychoroid disease, to neovascular pachychoroid disease
measure: Assess the chronology of choroidal changes in patients
time frame: 2 years
description: Determine the occurence of pachyvessles is the primary event, or consequent to inner choroidal attenuation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Xinyi Su, MBBS
role: Principal Investigator
affiliation: National University Hospital, Singapore
last name: Gemmy Cheung, MBBS
phone: +65 83828173
email: gemmy.cheung.c.m@singhealth.com.sg
last name: Kelvin Teo, MBBS
phone: +65 98000002
email: kelvin.teo.y.c@singhealth.com.sg
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Singapore National Eye Centre
investigator full name: Gemmy Cheung Chui Ming
investigator title: Professor
sharing ipd: No