<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/NCT03834753</url>
  </required_header>
  <id_info>
    <org_study_id>ONS-5010-002</org_study_id>
    <nct_id>NCT03834753</nct_id>
  </id_info>
  <brief_title>A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)</brief_title>
  <official_title>A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Outlook Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Outlook Therapeutics, 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>
      This research study will examine the safety and effectiveness of ONS-5010 in participants&#xD;
      with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as&#xD;
      compared with ranibizumab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2019</start_date>
  <completion_date type="Actual">July 8, 2021</completion_date>
  <primary_completion_date type="Actual">June 7, 2021</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)</measure>
    <time_frame>Baseline, 11 months</time_frame>
    <description>BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in the best corrected visual acuity</measure>
    <time_frame>Baseline, monthly to 11 months</time_frame>
    <description>BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who gain at least 10 letters in the best corrected visual acuity</measure>
    <time_frame>Baseline, 11 months</time_frame>
    <description>BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who gain at least 5 letters in the best corrected visual acuity</measure>
    <time_frame>Baseline, 11 months</time_frame>
    <description>BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity</measure>
    <time_frame>Baseline, 11 months</time_frame>
    <description>BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse</measure>
    <time_frame>Baseline, 11 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities</measure>
    <time_frame>11 months, 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">228</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <condition>Neovascular Age-related Macular Degeneration</condition>
  <condition>Wet Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ONS-5010</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ranibizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>bevacizumab</intervention_name>
    <description>1.25 mg, intravitreal injection</description>
    <arm_group_label>bevacizumab</arm_group_label>
    <other_name>ONS-5010</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ranibizumab</intervention_name>
    <description>0.5mg, intravitreal injection</description>
    <arm_group_label>ranibizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related&#xD;
             macular degeneration (AMD) in the study eye&#xD;
&#xD;
          -  Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 Snellen&#xD;
             equivalent)&#xD;
&#xD;
          -  Study eye must:&#xD;
&#xD;
               -  Have active leakage on Fluorescein Angiogram involving the fovea&#xD;
&#xD;
               -  Have edema involving the fovea&#xD;
&#xD;
               -  Be free of scarring, fibrosis, or atrophy involving the central foveal zone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous subfoveal focal laser photocoagulation in the study eye&#xD;
&#xD;
          -  Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month&#xD;
             preceding randomization&#xD;
&#xD;
          -  Any concurrent intraocular condition in the study eye that may require medical or&#xD;
             surgical intervention or contribute to vision loss within 1 year&#xD;
&#xD;
          -  Active intraocular inflammation (grade trace or above) in the study eye&#xD;
&#xD;
          -  Current vitreous haemorrhage in the study eye&#xD;
&#xD;
          -  Polypoidal choroidal vasculopathy (PCV) in the study eye&#xD;
&#xD;
          -  History of idiopathic or autoimmune-associated uveitis in either eye&#xD;
&#xD;
          -  Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye&#xD;
&#xD;
          -  Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg&#xD;
             despite treatment with anti-glaucoma medication)&#xD;
&#xD;
          -  Premenopausal women not using adequate contraception&#xD;
&#xD;
          -  Current treatment for active systemic infection&#xD;
&#xD;
          -  Known allergy to any component of the study drug or history of allergy to fluorescein&#xD;
             , not amenable to treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer M Kissner, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Outlook Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Arcadia</city>
        <state>California</state>
        <zip>91007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Campbell</city>
        <state>California</state>
        <zip>95008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95841</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>24233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Downers Grove</city>
        <state>Illinois</state>
        <zip>60615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Lemont</city>
        <state>Illinois</state>
        <zip>60439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Bloomfield</city>
        <state>New Jersey</state>
        <zip>07003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Chambersburg</city>
        <state>Pennsylvania</state>
        <zip>17201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Monroeville</city>
        <state>Pennsylvania</state>
        <zip>15146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Grapevine</city>
        <state>Texas</state>
        <zip>76051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Willow Park</city>
        <state>Texas</state>
        <zip>76807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </removed_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <disposition_first_submitted>November 16, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>November 16, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 19, 2021</disposition_first_posted>
  <last_update_submitted>February 15, 2022</last_update_submitted>
  <last_update_submitted_qc>February 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Subfoveal Choroidal Neovascularization</keyword>
  <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>
    <mesh_term>Choroidal Neovascularization</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Ranibizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will not be shared until all global regulatory filings are complete.</ipd_description>
  </patient_data>
  <!-- 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/NCT03834753
org study id: ONS-5010-002
nct id: NCT03834753
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This research study will examine the safety and effectiveness of ONS-5010 in participants
      with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as
      compared with ranibizumab.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)
time frame: Baseline, 11 months
description: BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
measure: Mean change in the best corrected visual acuity
time frame: Baseline, monthly to 11 months
description: BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
measure: Proportion of participants who gain at least 10 letters in the best corrected visual acuity
time frame: Baseline, 11 months
description: BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
measure: Proportion of participants who gain at least 5 letters in the best corrected visual acuity
time frame: Baseline, 11 months
description: BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
measure: Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity
time frame: Baseline, 11 months
description: BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
measure: Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
time frame: Baseline, 11 months
measure: Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
time frame: 11 months, 12 months
arm group label: bevacizumab
arm group type: Experimental
description: ONS-5010
arm group label: ranibizumab
arm group type: Active Comparator
intervention type: Biological
intervention name: bevacizumab
description: 1.25 mg, intravitreal injection
arm group label: bevacizumab
other name: ONS-5010
intervention type: Biological
intervention name: ranibizumab
description: 0.5mg, intravitreal injection
arm group label: ranibizumab
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer M Kissner, PhD
role: Study Director
affiliation: Outlook Therapeutics, Inc.
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country: United States
country: Australia
country: New Zealand
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration
mesh term: Choroidal Neovascularization
mesh term: Bevacizumab
mesh term: Ranibizumab
sharing ipd: Undecided
ipd description: Data will not be shared until all global regulatory filings are complete.