<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/NCT04481386</url>
  </required_header>
  <id_info>
    <org_study_id>BFC-1401</org_study_id>
    <nct_id>NCT04481386</nct_id>
  </id_info>
  <brief_title>A Phase I Study of Vitargus® in Vitrectomy</brief_title>
  <official_title>A Phase I, Safety and Tolerability Study of Vitargus® in Vitrectomy Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioFirst Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioFirst Corporation</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Objectives:&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
      • To evaluate the safety/tolerability of a single intravitreal (IVT) dose of BFC-1401 in&#xD;
      participants as a vitreous substitute during vitrectomy surgery.&#xD;
&#xD;
      Secondary Objective&#xD;
&#xD;
        -  To assess retinal attachment and hydrogel degradation at Day 120.&#xD;
&#xD;
        -  To assess best corrected visual acuity (BCVA) after vitrectomy surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">July 2, 2018</completion_date>
  <primary_completion_date type="Actual">July 2, 2018</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety/tolerability: Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>120 days</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events. Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA), and data summarised by System Organ Class and preferred term.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy for best corrected visual acuity (BCVA); retinal attachment and hydrogel degradation</measure>
    <time_frame>120 days</time_frame>
    <description>To assess best corrected visual acuity (BCVA) by LogMAR change from baseline over time after vitrectomy surgery.&#xD;
To assess retinal attachment and hydrogel degradation by slit lamp biomicroscopy exam findings, dilated ophthalmoscopy exam findings, colour fundus photography, and OCT findings over time after vitrectomy surgery.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Vitreo-retinal Surgery</condition>
  <arm_group>
    <arm_group_label>Active arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with a diagnosis of retinal detachment or vitreous haemorrhage, who are scheduled for vitrectomy surgery with a vitreous substitute</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vitargus, BFC-1401</intervention_name>
    <description>A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.</description>
    <arm_group_label>Active arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female adults, aged 18 years or older at screening.&#xD;
&#xD;
          2. a) Diagnosis of Diagnosis of Diagnosis of Diagnosis of complex or rhegmatogenous&#xD;
             retinal detachment, or chronic retinal detachment with failure of gas or silicone oil&#xD;
             treatment, OR b) Diagnosis of any vitreous haemorrhage that requires vitrectomy&#xD;
             surgery&#xD;
&#xD;
          3. BCVA of 20/40 to 20/2000.&#xD;
&#xD;
          4. Scheduled vitrectomy with vitreous substitute.&#xD;
&#xD;
          5. Must be able and willing to provide written informed consent, attend all scheduled&#xD;
             visits and comply with all study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A participant meeting any of the following criteria was to be excluded from the study:&#xD;
&#xD;
          1. Any active intraocular or periocular infection or inflammation.&#xD;
&#xD;
          2. Only one functional eye.&#xD;
&#xD;
          3. Ocular disorders in the study eye that may confound the interpretation of the study&#xD;
             results; macular oedema not requiring vitrectomy surgery, choroidal&#xD;
             neovascularisation.&#xD;
&#xD;
          4. High refractive error demonstrating &gt;6 diopters of myopia.&#xD;
&#xD;
          5. Any ophthalmic condition that reduces the clarity of the optical media that interferes&#xD;
             with ophthalmic examination and adequate imaging (advanced cataract or corneal&#xD;
             opacities).&#xD;
&#xD;
          6. Uncontrolled glaucoma defined as intraocular pressure &gt; 30 mmHg on maximal therapy.&#xD;
&#xD;
          7. Aphakia or absence of the posterior capsule.&#xD;
&#xD;
          8. Known hypersensitivity to hyaluronic acid or ADH.&#xD;
&#xD;
          9. Uncontrolled blood pressure defined as systolic value ≥ 160 mmHg or diastolic value&#xD;
             ≥100 mmHg at screening.&#xD;
&#xD;
         10. Uncontrolled diabetes defined as glycated haemoglobin (HbA1c) &gt; 12%.&#xD;
&#xD;
         11. Stroke or myocardial infarction within 90 days of baseline.&#xD;
&#xD;
         12. Severe generalised disease resulting in a life expectancy shorter than 1 year.&#xD;
&#xD;
         13. Currently pregnant or breastfeeding.&#xD;
&#xD;
         14. Women of child-bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant, unless they are using effective methods of contraception during&#xD;
             dosing of study treatment. Effective contraception methods included:&#xD;
&#xD;
               -  Total abstinence (when this is in line with the preferred and usual lifestyle of&#xD;
                  the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal,&#xD;
                  post-ovulation methods) was not acceptable.&#xD;
&#xD;
               -  Female sterilisation (surgical bilateral oopthorectomy with or without&#xD;
                  hysterectomy) or tubal ligation at least six weeks before taking study treatment.&#xD;
                  In case of oophorectomy alone, this was acceptable only when the reproductive&#xD;
                  status of the woman was confirmed by follow-up hormone level assessment.&#xD;
&#xD;
               -  Male sterilisation (at least 6 months prior to screening). For female&#xD;
                  participants on the study, the vasectomised male partner was to be the sole&#xD;
                  partner for that participant.&#xD;
&#xD;
               -  Barrier methods of contraception: Condom or Occlusive cap (diaphragm or&#xD;
                  cervical/vault caps).&#xD;
&#xD;
               -  Use of oral, injected or implanted hormonal methods of contraception or other&#xD;
                  forms of hormonal contraception that have comparable efficacy (failure rate&lt;1%),&#xD;
                  for example hormone vaginal ring or transdermal hormone contraception.&#xD;
&#xD;
               -  Placement of an intrauterine device or intrauterine system.&#xD;
&#xD;
               -  In the case of use of oral contraception, women were to be stable on the same&#xD;
                  pill for a minimum of 3 months before taking study treatment.&#xD;
&#xD;
               -  The use of an effective contraception method was to continue for 4 months&#xD;
                  post-vitrectomy and injection of the investigational product, in line with the&#xD;
                  follow-up period of the study.&#xD;
&#xD;
               -  Because the experimental investigational product in this study may affect an&#xD;
                  unborn baby, males participating in this study were not to father a baby while on&#xD;
                  the study, and for 4 months following the injection of study medication.&#xD;
&#xD;
               -  Women were considered post-menopausal and not of child-bearing potential if they&#xD;
                  had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical&#xD;
                  profile (e.g. age appropriate, history of vasomotor symptoms) or had surgical&#xD;
                  bilateral oophorectomy (with or without hysterectomy) or tubal ligation, at least&#xD;
                  six weeks prior to the study. In the case of oophorectomy alone, only when the&#xD;
                  reproductive status of the woman was confirmed by follow-up hormone level&#xD;
                  assessment was she considered to be not of child-bearing potential.&#xD;
&#xD;
         15. Participation in any study involving an investigational drug or device within the past&#xD;
             30 days or ongoing participation in a study with an investigational drug or device.&#xD;
&#xD;
         16. Any clinical evidence that the Investigator felt would place the participant at&#xD;
             increased risk with the investigational product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Chang, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sydney Retina Clinic | Medical Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sydney Retina Clinic and Day Surgery</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <link>
    <url>http://www.globenewswire.com/news-release/2019/10/15/1930092/0/en/American-BriVision-Highlights-Results-from-Vitargus-First-in-Human-Clinical-Trial.html</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04481386
org study id: BFC-1401
nct id: NCT04481386
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery
Study Objectives:

      Primary Objective

      • To evaluate the safety/tolerability of a single intravitreal (IVT) dose of BFC-1401 in
      participants as a vitreous substitute during vitrectomy surgery.

      Secondary Objective

        -  To assess retinal attachment and hydrogel degradation at Day 120.

        -  To assess best corrected visual acuity (BCVA) after vitrectomy surgery.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery
primary purpose: Treatment
masking: None (Open Label)
measure: Safety/tolerability: Incidence of Treatment-Emergent Adverse Events
time frame: 120 days
description: Incidence of Treatment-Emergent Adverse Events. Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA), and data summarised by System Organ Class and preferred term.
measure: Efficacy for best corrected visual acuity (BCVA); retinal attachment and hydrogel degradation
time frame: 120 days
description: To assess best corrected visual acuity (BCVA) by LogMAR change from baseline over time after vitrectomy surgery.
To assess retinal attachment and hydrogel degradation by slit lamp biomicroscopy exam findings, dilated ophthalmoscopy exam findings, colour fundus photography, and OCT findings over time after vitrectomy surgery.
arm group label: Active arm
arm group type: Experimental
description: Participants with a diagnosis of retinal detachment or vitreous haemorrhage, who are scheduled for vitrectomy surgery with a vitreous substitute
intervention type: Device
intervention name: Vitargus, BFC-1401
description: A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.
arm group label: Active arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Chang, MD, Ph.D
role: Principal Investigator
affiliation: Sydney Retina Clinic | Medical Director
facility: 
country: Australia
url: http://www.globenewswire.com/news-release/2019/10/15/1930092/0/en/American-BriVision-Highlights-Results-from-Vitargus-First-in-Human-Clinical-Trial.html
description: Related Info
responsible party type: Sponsor
sharing ipd: No