<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/NCT03793400</url>
  </required_header>
  <id_info>
    <org_study_id>180916</org_study_id>
    <nct_id>NCT03793400</nct_id>
  </id_info>
  <brief_title>Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor</brief_title>
  <official_title>Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate&#xD;
      inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial&#xD;
      factor treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate&#xD;
      inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial&#xD;
      factor treatment.&#xD;
&#xD;
      The age, sex, best corrected visual acuity (BCVA) in Snellen chart, and refractive status for&#xD;
      each patient were recorded. All patients had thorough clinical examinations, including slit&#xD;
      lamp biomicroscopy, indirect ophthalmoloscopy, and spectral domain optical coherence&#xD;
      tomography during each visit. Fundus photography, fluorescein angiography, and indocyanine&#xD;
      angiography were performed on all patients. OCT angiography was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2018</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">April 13, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Wilcoxon Signed-Rank test</measure>
    <time_frame>Baseline,48 month.</time_frame>
    <description>A statistical comparison of average of two dependent samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual acuity</measure>
    <time_frame>Baseline,48 month.</time_frame>
    <description>visual acuity in logMAR</description>
  </secondary_outcome>
  <enrollment type="Actual">22</enrollment>
  <condition>Choroidal Neovascularization</condition>
  <condition>Punctate Inner Choroidopathy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab Injection</intervention_name>
    <description>Anti-vascular endothelial growth factor (VEGF)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators included punctate inner choroidopathy or multifocal choroiditis with&#xD;
        active choroidal neovascularization patients with follow up over 4 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients were punctate inner choroidopathy or multifocal choroiditis with active&#xD;
             choroidal neovascularization.&#xD;
&#xD;
          2. Follow up over 4 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients were not punctate inner choroidopathy or multifocal choroiditis with active&#xD;
             choroidal neovascularization&#xD;
&#xD;
          2. Patients were punctate inner choroidopathy or multifocal choroiditis with active&#xD;
             choroidal neovascularization but loss follow over 1 year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 6, 2019</last_update_submitted>
  <last_update_submitted_qc>January 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhua Christian Hospital</investigator_affiliation>
    <investigator_full_name>San Ni Chen</investigator_full_name>
    <investigator_title>Department of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>punctate inner choroidopathy</keyword>
  <keyword>multifocal choroidits</keyword>
  <keyword>choroidal neovascularization</keyword>
  <keyword>anti-VEGF</keyword>
  <keyword>long-term outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Choroid Diseases</mesh_term>
    <mesh_term>Choroiditis</mesh_term>
    <mesh_term>White Dot Syndromes</mesh_term>
    <mesh_term>Multifocal Choroiditis</mesh_term>
    <mesh_term>Neovascularization, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
  </intervention_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/NCT03793400
org study id: 180916
nct id: NCT03793400
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate
      inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial
      factor treatment.
To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate
      inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial
      factor treatment.

      The age, sex, best corrected visual acuity (BCVA) in Snellen chart, and refractive status for
      each patient were recorded. All patients had thorough clinical examinations, including slit
      lamp biomicroscopy, indirect ophthalmoloscopy, and spectral domain optical coherence
      tomography during each visit. Fundus photography, fluorescein angiography, and indocyanine
      angiography were performed on all patients. OCT angiography was performed.
observational model: Case-Only
time perspective: Retrospective
measure: Wilcoxon Signed-Rank test
time frame: Baseline,48 month.
description: A statistical comparison of average of two dependent samples
measure: visual acuity
time frame: Baseline,48 month.
description: visual acuity in logMAR
intervention type: Drug
intervention name: Bevacizumab Injection
description: Anti-vascular endothelial growth factor (VEGF)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Changhua Christian Hospital
investigator full name: San Ni Chen
investigator title: Department of Ophthalmology
mesh term: Choroidal Neovascularization
mesh term: Choroid Diseases
mesh term: Choroiditis
mesh term: White Dot Syndromes
mesh term: Multifocal Choroiditis
mesh term: Neovascularization, Pathologic
mesh term: Bevacizumab
sharing ipd: Undecided