<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/NCT04422899</url>
  </required_header>
  <id_info>
    <org_study_id>AIV007-E01</org_study_id>
    <nct_id>NCT04422899</nct_id>
  </id_info>
  <brief_title>Effect of Intravitreally Administered AIV007 in Subjects With nAMD</brief_title>
  <official_title>A Phase I Study of the Safety, Pharmacokinetics, and Duration of Effect of Intravitreally Administered AIV007 Gel Suspension in Subjects With Neovascular Age-Related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AiViva BioPharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AiViva BioPharma, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine safety, pharmacokinetics, and duration of effect of intravitreally administered&#xD;
      AIV007 gel suspension in subjects with neovascular age-related macular degeneration&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2020</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">September 29, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>approximately 224 days</time_frame>
    <description>Incidence of adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in BCVA</measure>
    <time_frame>approximately 224 days</time_frame>
    <description>Number of ETDRS letters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in central subfield thickness as measured by optical coherence tomography</measure>
    <time_frame>approximately 224 days</time_frame>
    <description>OCT read by a central reading center</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time to escape medication</measure>
    <time_frame>approximately 224 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Neovascular Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>AIV007 Treatment Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravitreal, Dose 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIV007 Treatment Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravitreal, Dose 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIV007 Treatment Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravitreal, Dose 3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AIV007</intervention_name>
    <description>intravitreal</description>
    <arm_group_label>AIV007 Treatment Dose 1</arm_group_label>
    <arm_group_label>AIV007 Treatment Dose 2</arm_group_label>
    <arm_group_label>AIV007 Treatment Dose 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects aged ≥ 50 years&#xD;
&#xD;
          2. Subjects must provide written informed consent before any study-related procedures are&#xD;
             performed&#xD;
&#xD;
          3. Active subfoveal CNV in the study eye secondary to AMD that has previously been&#xD;
             treated with at least 3 intravitreal injections of an anti-VEGF agent&#xD;
&#xD;
          4. BCVA in the study eye&#xD;
&#xD;
               1. Sentinel subjects only: 65 ETDRS letters (20/50 Snellen equivalent) or worse&#xD;
&#xD;
               2. All other subjects: 78 to 35 ETDRS letters (20/32 to 20/200 Snellen equivalent)&#xD;
&#xD;
          5. Clear ocular media and adequate pupil dilation in both eyes to permit good quality&#xD;
             photographic imaging&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF&#xD;
             IVT injection, eg, cell therapy, brachytherapy, gene therapy&#xD;
&#xD;
          2. Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline&#xD;
&#xD;
          3. Presence of diabetic retinopathy or glaucoma in either eye&#xD;
&#xD;
          4. Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters&#xD;
             of myopia (prior to cataract or refractive surgery)&#xD;
&#xD;
          5. Presence of active infection or inflammation within 30 days prior to screening&#xD;
&#xD;
          6. Presence of contraindications to anti-VEGF treatment, including myocardial infarction,&#xD;
             any cardiac event requiring hospitalization, treatment for acute congestive heart&#xD;
             failure, transient ischemic attack, or stroke within the last 3 months of baseline&#xD;
&#xD;
          7. Uncontrolled hypertension or diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Retina Research Institute of Texas</name>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 11, 2022</last_update_submitted>
  <last_update_submitted_qc>May 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 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>
    <mesh_term>Wet 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/NCT04422899
org study id: AIV007-E01
nct id: NCT04422899
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To determine safety, pharmacokinetics, and duration of effect of intravitreally administered
      AIV007 gel suspension in subjects with neovascular age-related macular degeneration
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: approximately 224 days
description: Incidence of adverse events
measure: Mean change from baseline in BCVA
time frame: approximately 224 days
description: Number of ETDRS letters
measure: Mean change from baseline in central subfield thickness as measured by optical coherence tomography
time frame: approximately 224 days
description: OCT read by a central reading center
measure: Mean time to escape medication
time frame: approximately 224 days
arm group label: AIV007 Treatment Dose 1
arm group type: Experimental
description: Intravitreal, Dose 1
arm group label: AIV007 Treatment Dose 2
arm group type: Experimental
description: Intravitreal, Dose 2
arm group label: AIV007 Treatment Dose 3
arm group type: Experimental
description: Intravitreal, Dose 3
intervention type: Drug
intervention name: AIV007
description: intravitreal
arm group label: AIV007 Treatment Dose 1
arm group label: AIV007 Treatment Dose 2
arm group label: AIV007 Treatment Dose 3
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration