<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/NCT01678872</url>
  </required_header>
  <id_info>
    <org_study_id>RS1/002/11</org_study_id>
    <nct_id>NCT01678872</nct_id>
  </id_info>
  <brief_title>A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration</brief_title>
  <official_title>A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford BioMedica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oxford BioMedica</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the long term safety of an experimental gene transfer&#xD;
      agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">March 2029</completion_date>
  <primary_completion_date type="Anticipated">March 2029</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of adverse events</measure>
    <time_frame>15 years</time_frame>
    <description>The number of subjects with treatment emergent adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in BCVA.</measure>
    <time_frame>15 years</time_frame>
    <description>The change from baseline in Best Corrective Visual Acuity.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Age-Related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Long Term Follow up</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Long Term follow up of patients who received RetinoStat in a previous study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RetinoStat</intervention_name>
    <description>Long Term Follow up of patients who received RetinoStat in a previous study</description>
    <arm_group_label>Long Term Follow up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have received a subretinal injection of RetinoStat&#xD;
&#xD;
          -  Must have been enrolled in Protocol RS1/001/10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Did not receive RetinoStat® as part of the RS1/001/10 protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Campochiaro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>John Hopkins University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Hospitals &amp; Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hopkins University Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287-9277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>November 2022</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</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>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01678872
org study id: RS1/002/11
nct id: NCT01678872
lead sponsor: 
has dmc: Yes
The purpose of this study is to examine the long term safety of an experimental gene transfer
      agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The incidence of adverse events
time frame: 15 years
description: The number of subjects with treatment emergent adverse events.
measure: The change from baseline in BCVA.
time frame: 15 years
description: The change from baseline in Best Corrective Visual Acuity.
arm group label: Long Term Follow up
arm group type: Other
description: Long Term follow up of patients who received RetinoStat in a previous study.
intervention type: Drug
intervention name: RetinoStat
description: Long Term Follow up of patients who received RetinoStat in a previous study
arm group label: Long Term Follow up
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Campochiaro, MD
role: Principal Investigator
affiliation: John Hopkins University Hospital
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration