<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/NCT03297684</url>
  </required_header>
  <id_info>
    <org_study_id>AERA101</org_study_id>
    <nct_id>NCT03297684</nct_id>
  </id_info>
  <brief_title>Assessment of Biomarker Profile in Diabetic Macular Edema With Intravitreal Aflibercept Injection</brief_title>
  <official_title>Assessment of Biomarker Profile in Diabetic Macular Edema in Response to Treatment With Intravitreal Aflibercept</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Eye Research Associates</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advanced Eye Research Associates</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the biomarker profile in diabetic macular edema patients in response to&#xD;
      intravitreal aflibercept injection. Patients with diabetic macular edema who meet study&#xD;
      requirements will receive monthly intravitreal injections of aflibercept as approved by FDA&#xD;
      for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each&#xD;
      injection for laboratory evaluation of biomarkers present before, during and after treatment&#xD;
      with aflibercept.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study objective is to better understand the pathophysiology of diabetic macular edema (DME)&#xD;
      by defining the factors that participate in the disease process or may be good biomarkers for&#xD;
      disease progression. Study will investigate the temporal relationship between the course of&#xD;
      treatment with anti-VEGF therapy and levels of candidate biomarkers previously identified to&#xD;
      determine which biomarkers are affected by anti-VEGF therapy with aflibercept. Study will&#xD;
      correlate response to therapy to particular biomarkers and attempt to identify those&#xD;
      associated with resistance to therapy for DME. Biomarker data will be correlated with serial&#xD;
      clinical evaluation of disease progression. 40 subjects with clinically significant DME who&#xD;
      plan to undergo anti-VEGF therapy will be treated with intravitreal aflibercept monthly for 6&#xD;
      months. At each visit aqueous humor will be collected and stored (6 samples per patient). At&#xD;
      termination of study all specimens will be analyzed for biomarkers identified from previous&#xD;
      studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 11, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure biomarkers in aqueous humor from individuals with DME</measure>
    <time_frame>2 years</time_frame>
    <description>Identify temporal effects of treatment with intravitreal afflibercept</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept Injection [Eylea]</intervention_name>
    <description>Intravitreal injection aflibercept</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Aqueous humor&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        individuals with DME from the Dartmouth, MA geographic area who are patients of Advanced&#xD;
        Eye Centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis type 1 or type 2 diabetes&#xD;
&#xD;
          -  Clinical DME as assessed by OCT&#xD;
&#xD;
          -  Well controlled glaucoma on medications but not on prostaglandin analogues&#xD;
&#xD;
          -  Mild Age Related Macular Degeneration (AMD)&#xD;
&#xD;
          -  Visual acuity between 73 and 5 ETDRS letters (20/40 -20/800 on eye chart)&#xD;
&#xD;
          -  Willing and able to participate and to comply with clinic visits and procedures&#xD;
&#xD;
          -  Provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate or inability to understand or sign informed consent&#xD;
&#xD;
          -  Poor eye fluid that would preclude adequate testing&#xD;
&#xD;
          -  Prior intraocular treatment with anti-VEGF or focal laser treatment within 90 days&#xD;
&#xD;
          -  Corticosteroid injections within 120 days&#xD;
&#xD;
          -  Active proliferative diabetic retinopathy&#xD;
&#xD;
          -  Intraocular pressure greater than 25 mm Hg&#xD;
&#xD;
          -  Any previous vitrectomy surgery&#xD;
&#xD;
          -  Current use of systemic anti-VEGF agents&#xD;
&#xD;
          -  Shallow anterior eye chamber in eye with natural lens&#xD;
&#xD;
          -  Non-diabetic related macular swelling (retinal vein occlusion)&#xD;
&#xD;
          -  History of ocular disease&#xD;
&#xD;
          -  Systemic disease other than diabetes mellitus&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  Sexually active men or women of childbearing potential who are unwilling to practice&#xD;
             adequate birth control during study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary M Chatterton, MBA, JD</last_name>
    <role>Study Director</role>
    <affiliation>Advanced Eye Research Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Eye Centers</name>
      <address>
        <city>South Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>February 17, 2022</last_update_submitted>
  <last_update_submitted_qc>February 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 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 Edema</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>


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/NCT03297684
org study id: AERA101
nct id: NCT03297684
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To assess the biomarker profile in diabetic macular edema patients in response to
      intravitreal aflibercept injection. Patients with diabetic macular edema who meet study
      requirements will receive monthly intravitreal injections of aflibercept as approved by FDA
      for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each
      injection for laboratory evaluation of biomarkers present before, during and after treatment
      with aflibercept.
Study objective is to better understand the pathophysiology of diabetic macular edema (DME)
      by defining the factors that participate in the disease process or may be good biomarkers for
      disease progression. Study will investigate the temporal relationship between the course of
      treatment with anti-VEGF therapy and levels of candidate biomarkers previously identified to
      determine which biomarkers are affected by anti-VEGF therapy with aflibercept. Study will
      correlate response to therapy to particular biomarkers and attempt to identify those
      associated with resistance to therapy for DME. Biomarker data will be correlated with serial
      clinical evaluation of disease progression. 40 subjects with clinically significant DME who
      plan to undergo anti-VEGF therapy will be treated with intravitreal aflibercept monthly for 6
      months. At each visit aqueous humor will be collected and stored (6 samples per patient). At
      termination of study all specimens will be analyzed for biomarkers identified from previous
      studies.
observational model: Case-Only
time perspective: Prospective
measure: Measure biomarkers in aqueous humor from individuals with DME
time frame: 2 years
description: Identify temporal effects of treatment with intravitreal afflibercept
intervention type: Drug
intervention name: Aflibercept Injection [Eylea]
description: Intravitreal injection aflibercept
Aqueous humor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mary M Chatterton, MBA, JD
role: Study Director
affiliation: Advanced Eye Research Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema
mesh term: Aflibercept
sharing ipd: No