xml: <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/NCT06011798</url>
    </required_header>
    <id_info>
      <org_study_id>UBX1325-04</org_study_id>
      <nct_id>NCT06011798</nct_id>
    </id_info>
    <brief_title>Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME</brief_title>
    <acronym>ASPIRE</acronym>
    <official_title>A Phase 2b, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With Diabetic Macular Edema</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Unity Biotechnology, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Unity Biotechnology, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to assess the efficacy and safety of multiple doses of&#xD;
        foselutoclax (UBX1325) in patients with Diabetic Macular Edema. The main question[s] the&#xD;
        study aims to answer are:&#xD;
  &#xD;
          -  Assess the efficacy of foselutoclax compared to aflibercept&#xD;
  &#xD;
          -  Assess the safety and tolerability of foselutoclax&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is intended to assess the efficacy and safety of foselutoclax , a phosphate&#xD;
        pro-drug, and its active parent molecule (UBX0601, a BCL-xL inhibitor) following repeat&#xD;
        intravitreal (IVT) injections of foselutoclax in patients with Diabetic Macular Edema (DME).&#xD;
  &#xD;
        Approximately 40 patients will be enrolled and randomized 1:1 into either the foselutoclax&#xD;
        arm,10 μg given 8 weeks apart, or the control arm of aflibercept, 2 mg every 8 weeks in order&#xD;
        to assess the primary objective. All patients will be followed for approximately 24 weeks.&#xD;
  &#xD;
        The injector will be unmasked but the evaluator will remain masked throughout the study.&#xD;
  &#xD;
        This study will enroll participants ≥18 years of age with active DME disease despite&#xD;
        treatment, with best corrected visual acuity (BCVA) between 70 to 30 Early Treatment Diabetic&#xD;
        Retinopathy Study (ETDRS) letters (equivalent to 20/40 to 20/250 on the Snellen chart). Once&#xD;
        patients meet inclusion/exclusion criteria, patients will receive 3 run-in injections of&#xD;
        aflibercept approximately 4 weeks apart, with the last aflibercept injection 4-6 weeks prior&#xD;
        to Day 1.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean change from baseline in BCVA by ETDRS letter</measure>
      <time_frame>24 weeks</time_frame>
      <description>Mean change from baseline in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess other efficacy outcome - Changes in BCVA</measure>
      <time_frame>24 weeks</time_frame>
      <description>Changes in BCVA (ETDRS letters) from baseline to visits prior to Week 24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess other efficacy outcome - Changes in CST</measure>
      <time_frame>24 weeks</time_frame>
      <description>Change in Central Subfield Thickness (CST) as measured in microns from baseline to Week 24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess other efficacy outcome - ETDRS gains</measure>
      <time_frame>24 weeks</time_frame>
      <description>Proportion of participants gaining ≥15, ≥10, ≥5, or ≥0 ETDRS letters in BCVA from baseline in the Study Eye (SE) to week 24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess safety outcome - TEAE</measure>
      <time_frame>24 weeks</time_frame>
      <description>Percentage of participants with at least one treatment-emergent ocular adverse event (AE) in the SE or Fellow Eye (FE)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Diabetic Macular Edema</condition>
    <condition>Retinal Disease</condition>
    <condition>Macular Edema</condition>
    <condition>Diabetes Mellitus</condition>
    <condition>Diabetic Retinopathy</condition>
    <condition>Retinal Degeneration</condition>
    <condition>Retinal Diseases</condition>
    <condition>Eye Diseases</condition>
    <condition>Edema</condition>
    <arm_group>
      <arm_group_label>Anti-VEGF control arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>foselutoclax arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aflibercept</intervention_name>
      <description>Anti-VEGF control</description>
      <arm_group_label>Anti-VEGF control arm</arm_group_label>
      <arm_group_label>foselutoclax arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>foselutoclax</intervention_name>
      <description>Experimental drug</description>
      <arm_group_label>foselutoclax arm</arm_group_label>
      <other_name>UBX1325</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged ≥18 years.&#xD;
  &#xD;
            -  Patients with nonproliferative DR and DME&#xD;
  &#xD;
            -  Center-involved DME with Central Subfield Thickness (CST) ≥325-900 μm&#xD;
  &#xD;
            -  BCVA in the SE (most affected) of 70 to 30 ETDRS letters (equivalent to 20/40 to&#xD;
               20/250 on the Snellen chart)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Concurrent disease in the study eye (SE) or structural damage, other than DME, that&#xD;
               could compromise BCVA, prevent BCVA improvement, require medical or surgical&#xD;
               intervention during the study period, confound interpretation of the results, or&#xD;
               interfere with assessment of toxicity or Color Fundus Photography (CFP) in the SE.&#xD;
  &#xD;
            -  Significant media opacities, including cataract, or posterior capsule opacification,&#xD;
               which might interfere with VA, assessment of toxicity, or fundus imaging in either&#xD;
               eye.&#xD;
  &#xD;
            -  Any medical condition that is uncontrolled and may prevent participation in this&#xD;
               study, as determined by the Investigator or disqualify individuals from enrollment.&#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>Sharon Klier, MD, MPH</last_name>
      <role>Study Director</role>
      <affiliation>Unity Biotechnology, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sharon Klier, MD, MPH</last_name>
      <phone>650-513-0096</phone>
      <email>UBX1325_medicalmonitor@unitybiotechnology.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Clinical Operations</last_name>
      <phone>650-513-0096</phone>
      <email>clinops@unitybiotechnology.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>California Retina Consultants</name>
        <address>
          <city>Bakersfield</city>
          <state>California</state>
          <zip>93309</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Dante J Pieramici, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Bay Area Retina Associates</name>
        <address>
          <city>Walnut Creek</city>
          <state>California</state>
          <zip>94598</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Roger A Goldberg, MD, MBA</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Advanced Vision Research Institute</name>
        <address>
          <city>Longmont</city>
          <state>Colorado</state>
          <zip>80503</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Matthew W Manry, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Rand Eye Institute</name>
        <address>
          <city>Deerfield Beach</city>
          <state>Florida</state>
          <zip>33064</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Carl Danzig, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Florida Eye Associates</name>
        <address>
          <city>Melbourne</city>
          <state>Florida</state>
          <zip>32901</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Vrinda Hershberger, MD, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>EyeHealth Northwest</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97225</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Brian Chan-Kai, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Retina Consultants of Carolina</name>
        <address>
          <city>Greenville</city>
          <state>South Carolina</state>
          <zip>29605</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Chris Bergstrom, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Retina Center of Texas</name>
        <address>
          <city>Southlake</city>
          <state>Texas</state>
          <zip>76092</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jawad Qureshi, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>DME</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Macular Edema</mesh_term>
      <mesh_term>Retinal Diseases</mesh_term>
      <mesh_term>Diabetic Retinopathy</mesh_term>
      <mesh_term>Eye Diseases</mesh_term>
      <mesh_term>Retinal Degeneration</mesh_term>
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aflibercept</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011798
  org study id: UBX1325-04
  nct id: NCT06011798
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical trial is to assess the efficacy and safety of multiple doses of
        foselutoclax (UBX1325) in patients with Diabetic Macular Edema. The main question[s] the
        study aims to answer are:
  
          -  Assess the efficacy of foselutoclax compared to aflibercept
  
          -  Assess the safety and tolerability of foselutoclax
  This study is intended to assess the efficacy and safety of foselutoclax , a phosphate
        pro-drug, and its active parent molecule (UBX0601, a BCL-xL inhibitor) following repeat
        intravitreal (IVT) injections of foselutoclax in patients with Diabetic Macular Edema (DME).
  
        Approximately 40 patients will be enrolled and randomized 1:1 into either the foselutoclax
        arm,10 μg given 8 weeks apart, or the control arm of aflibercept, 2 mg every 8 weeks in order
        to assess the primary objective. All patients will be followed for approximately 24 weeks.
  
        The injector will be unmasked but the evaluator will remain masked throughout the study.
  
        This study will enroll participants ≥18 years of age with active DME disease despite
        treatment, with best corrected visual acuity (BCVA) between 70 to 30 Early Treatment Diabetic
        Retinopathy Study (ETDRS) letters (equivalent to 20/40 to 20/250 on the Snellen chart). Once
        patients meet inclusion/exclusion criteria, patients will receive 3 run-in injections of
        aflibercept approximately 4 weeks apart, with the last aflibercept injection 4-6 weeks prior
        to Day 1.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Mean change from baseline in BCVA by ETDRS letter
  time frame: 24 weeks
  description: Mean change from baseline in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter
  measure: Assess other efficacy outcome - Changes in BCVA
  time frame: 24 weeks
  description: Changes in BCVA (ETDRS letters) from baseline to visits prior to Week 24
  measure: Assess other efficacy outcome - Changes in CST
  time frame: 24 weeks
  description: Change in Central Subfield Thickness (CST) as measured in microns from baseline to Week 24
  measure: Assess other efficacy outcome - ETDRS gains
  time frame: 24 weeks
  description: Proportion of participants gaining ≥15, ≥10, ≥5, or ≥0 ETDRS letters in BCVA from baseline in the Study Eye (SE) to week 24
  measure: Assess safety outcome - TEAE
  time frame: 24 weeks
  description: Percentage of participants with at least one treatment-emergent ocular adverse event (AE) in the SE or Fellow Eye (FE)
  arm group label: Anti-VEGF control arm
  arm group type: Active Comparator
  description: Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
  arm group label: foselutoclax arm
  arm group type: Experimental
  description: Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
  intervention type: Drug
  intervention name: Aflibercept
  description: Anti-VEGF control
  arm group label: Anti-VEGF control arm
  arm group label: foselutoclax arm
  intervention type: Drug
  intervention name: foselutoclax
  description: Experimental drug
  arm group label: foselutoclax arm
  other name: UBX1325
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sharon Klier, MD, MPH
  role: Study Director
  affiliation: Unity Biotechnology, Inc.
  last name: Sharon Klier, MD, MPH
  phone: 650-513-0096
  email: UBX1325_medicalmonitor@unitybiotechnology.com
  last name: Clinical Operations
  phone: 650-513-0096
  email: clinops@unitybiotechnology.com
  facility: 
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  country: United States
  responsible party type: Sponsor
  mesh term: Macular Edema
  mesh term: Retinal Diseases
  mesh term: Diabetic Retinopathy
  mesh term: Eye Diseases
  mesh term: Retinal Degeneration
  mesh term: Edema
  mesh term: Aflibercept
  sharing ipd: No