<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/NCT01702441</url>
  </required_header>
  <id_info>
    <org_study_id>AKB-9778-CI-2002</org_study_id>
    <nct_id>NCT01702441</nct_id>
  </id_info>
  <brief_title>Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema</brief_title>
  <official_title>Phase 1b/2a Open Label, Multiple-Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pilot Efficacy, Pharmacokinetics and Pharmacodynamic Effects of 28 Day Repeat Subcutaneous Doses of AKB-9778 in Subjects With Diabetic Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aerpio Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aerpio Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and&#xD;
      pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections&#xD;
      daily for 28 days in patients with diabetic macular edema (DME).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of adverse events (AEs).</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in physical exams.</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in vital signs.</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in electrocardiograms (ECGs).</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in opthalmic exams.</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in clinical laboratory assay results.</measure>
    <time_frame>28 days</time_frame>
    <description>Blood chemistry, hematology and urinalysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of AKB-9778</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in optical tomography (OCT)-measured retinal thickness.</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in best corrected visual acuity (BCVA).</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Diabetic Macular Edema (DME)</condition>
  <arm_group>
    <arm_group_label>AKB-9778</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subcutaneous AKB-9778</intervention_name>
    <arm_group_label>AKB-9778</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The following is an abbreviated list of inclusion criteria:&#xD;
&#xD;
          -  Adults between 18 to 80 years of age, inclusive&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus (type 1 or type 2)&#xD;
&#xD;
          -  Decrease in vision determined to be primarily the result of DME in the study eye&#xD;
&#xD;
          -  Definite Retinal thickening due to diffuse DME involving the center of the macula in&#xD;
             the study eye&#xD;
&#xD;
          -  Mean central subfield thickness of at least 325 µm by OCT in the study eye&#xD;
&#xD;
          -  Early Treatment Diabetic Retinopathy Study (ETDRS) letter score BCVA ≤ 70 (20/40) in&#xD;
             the study eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The following is an abbreviated list of exclusion criteria:&#xD;
&#xD;
          -  Hemoglobin A1C (HbA1C) ≥ 11.5%&#xD;
&#xD;
          -  History of any of the following in the study eye (however, the following are not&#xD;
             exclusionary in the fellow eye):&#xD;
&#xD;
               1. Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to&#xD;
                  Screening&#xD;
&#xD;
               2. Prior pars plana vitrectomy within 12 weeks prior to Screening&#xD;
&#xD;
               3. Any ocular surgery within 12 weeks prior to Screening&#xD;
&#xD;
               4. YAG capsulotomy within 7 days prior to Screening&#xD;
&#xD;
               5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior&#xD;
                  to Screening or prior treatment with intravitreal anti-VEGF treatment within 1&#xD;
                  month of Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Peters, MD</last_name>
    <role>Study Director</role>
    <affiliation>Aerpio Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <disposition_first_submitted>March 9, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>March 9, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 27, 2015</disposition_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 27, 2015</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 Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01702441
org study id: AKB-9778-CI-2002
nct id: NCT01702441
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and
      pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections
      daily for 28 days in patients with diabetic macular edema (DME).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence and severity of adverse events (AEs).
time frame: 28 days
measure: Change from baseline in physical exams.
time frame: 28 days
measure: Change from baseline in vital signs.
time frame: 28 days
measure: Change from baseline in electrocardiograms (ECGs).
time frame: 28 days
measure: Change from baseline in opthalmic exams.
time frame: 28 days
measure: Change from baseline in clinical laboratory assay results.
time frame: 28 days
description: Blood chemistry, hematology and urinalysis.
measure: Pharmacokinetics of AKB-9778
time frame: Day 1 and Day 14
description: Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).
measure: Change from baseline in optical tomography (OCT)-measured retinal thickness.
time frame: 28 days
measure: Change from baseline in best corrected visual acuity (BCVA).
time frame: 28 days
arm group label: AKB-9778
arm group type: Experimental
description: Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days.
intervention type: Drug
intervention name: Subcutaneous AKB-9778
arm group label: AKB-9778
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kevin Peters, MD
role: Study Director
affiliation: Aerpio Therapeutics
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema