<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/NCT03281005</url>
  </required_header>
  <id_info>
    <org_study_id>CRE170041</org_study_id>
    <nct_id>NCT03281005</nct_id>
  </id_info>
  <brief_title>Development of Visual Function Evaluation Method</brief_title>
  <official_title>Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</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>
      The objective of this study is to develop the comprehensive visual function evaluation method&#xD;
      in severe visually impaired patient&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and&#xD;
      3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional&#xD;
      examination will be performed using alternative devices imported outside Japan on subjects&#xD;
      who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A,&#xD;
      Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved&#xD;
      methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers&#xD;
      to obtain comparative data using devices used in Part 1B.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">November 21, 2019</completion_date>
  <primary_completion_date type="Actual">November 21, 2019</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>Slit-lamp microscopy in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Slit-lamp microscopy in Part 1B and 3</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Optical Coherence Tomography (OCT) test in Part 1A and 2</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual acuity test with ETDRS in Part 1B</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function and the quality of life (QOL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function and QOL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the psychological adjustment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily living task dependent on vision (DLTV) in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess QOL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Table test in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metropsis test in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low vision evaluator (LoVE) in Part 1A</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White flash visual evoked potential (VEP) test in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White flash VEP test in Part 1B and 3</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Color flash VEP test in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Color flash VEP test in Part 1B and 3</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrically evoked response (EER) test in Part 1A and 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EER test in Part 1B and 3</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White flash electroretinography test in Part 1A, 1B, 2 and 3</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pupillary function test in Part 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pupillary function test in Part 1B and 3</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Full field stimulus threshold testing (FST) in Part 2</measure>
    <time_frame>Up to week 8</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FST in Part 1B</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess the visual function</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Retinitis Pigmentosa</condition>
  <arm_group>
    <arm_group_label>Retinitis pigmentosa in Part 1A</arm_group_label>
    <description>Retinitis pigmentosa patients with severe visual impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retinitis pigmentosa in Part 1B</arm_group_label>
    <description>Retinitis pigmentosa patients with severe visual impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retinitis pigmentosa in Part 2</arm_group_label>
    <description>Retinitis pigmentosa patients with severe visual impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers in Part 3</arm_group_label>
    <description>Healthy volunteers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Retinitis pigmentosa, healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for patients with retinitis pigmentosa:&#xD;
&#xD;
          -  Age: ≥ 20 years&#xD;
&#xD;
          -  Subjects with severe visual disturbance (count-fingers or worse vision for severe&#xD;
             eyes) at the time of obtaining the consent&#xD;
&#xD;
        Inclusion Criteria for healthy Volunteers:&#xD;
&#xD;
          -  Age: ≥ 35 and ≤ 75 years&#xD;
&#xD;
          -  Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe&#xD;
             refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and&#xD;
             pupillary function test at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have participated in any other clinical trial or clinical study involving&#xD;
             visual function evaluation within 6 months&#xD;
&#xD;
          -  Subjects who have history of surgery, past history, and complications (cardiac/&#xD;
             hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing&#xD;
             marked loss of visual field, and uveitis etc.) that potentially affect evaluation and&#xD;
             safety of the study&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Subjects who are judged that continuation of the study is difficult during the study&#xD;
             period&#xD;
&#xD;
          -  Subjects who are employed by the company sponsoring this study, an organization or&#xD;
             institution related to this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site JP00001</name>
      <address>
        <city>Meguro-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 5, 2020</last_update_submitted>
  <last_update_submitted_qc>March 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Retinitis pigmentosa</keyword>
  <keyword>Visual function evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinitis</mesh_term>
    <mesh_term>Retinitis Pigmentosa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </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/NCT03281005
org study id: CRE170041
nct id: NCT03281005
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to develop the comprehensive visual function evaluation method
      in severe visually impaired patient
This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and
      3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional
      examination will be performed using alternative devices imported outside Japan on subjects
      who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A,
      Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved
      methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers
      to obtain comparative data using devices used in Part 1B.
observational model: Case-Control
time perspective: Prospective
measure: Slit-lamp microscopy in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function
measure: Slit-lamp microscopy in Part 1B and 3
time frame: Day 1
description: To assess the visual function
measure: Optical Coherence Tomography (OCT) test in Part 1A and 2
time frame: Day 1
description: To assess the visual function
measure: Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function
measure: Visual acuity test with ETDRS in Part 1B
time frame: Day 1
description: To assess the visual function
measure: The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function and the quality of life (QOL)
measure: The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function and QOL
measure: Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2
time frame: Up to week 8
description: To assess the psychological adjustment
measure: Daily living task dependent on vision (DLTV) in Part 1A and 2
time frame: Up to week 8
description: To assess QOL
measure: Table test in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function
measure: Metropsis test in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function
measure: Low vision evaluator (LoVE) in Part 1A
time frame: Up to week 8
description: To assess the visual function
measure: White flash visual evoked potential (VEP) test in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function
measure: White flash VEP test in Part 1B and 3
time frame: Day 1
description: To assess the visual function
measure: Color flash VEP test in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function
measure: Color flash VEP test in Part 1B and 3
time frame: Day 1
description: To assess the visual function
measure: Electrically evoked response (EER) test in Part 1A and 2
time frame: Up to week 8
description: To assess the visual function
measure: EER test in Part 1B and 3
time frame: Day 1
description: To assess the visual function
measure: White flash electroretinography test in Part 1A, 1B, 2 and 3
time frame: Day 1
description: To assess the visual function
measure: Pupillary function test in Part 2
time frame: Up to week 8
description: To assess the visual function
measure: Pupillary function test in Part 1B and 3
time frame: Day 1
description: To assess the visual function
measure: Full field stimulus threshold testing (FST) in Part 2
time frame: Up to week 8
description: To assess the visual function
measure: FST in Part 1B
time frame: Day 1
description: To assess the visual function
arm group label: Retinitis pigmentosa in Part 1A
description: Retinitis pigmentosa patients with severe visual impairment
arm group label: Retinitis pigmentosa in Part 1B
description: Retinitis pigmentosa patients with severe visual impairment
arm group label: Retinitis pigmentosa in Part 2
description: Retinitis pigmentosa patients with severe visual impairment
arm group label: Healthy volunteers in Part 3
description: Healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Retinitis
mesh term: Retinitis Pigmentosa
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."