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/NCT06007690</url>
    </required_header>
    <id_info>
      <org_study_id>AU-011-301</org_study_id>
      <nct_id>NCT06007690</nct_id>
    </id_info>
    <brief_title>A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma</brief_title>
    <acronym>CoMpass</acronym>
    <official_title>A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aura Biosciences</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aura Biosciences</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective is to determine the safety and efficacy of belzupacap sarotalocan&#xD;
        (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or&#xD;
        small choroidal melanoma (CM).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to&#xD;
        establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration&#xD;
        in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug&#xD;
        product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser&#xD;
        photoactivation device.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2026</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>
      <masking_description>Subject, Assessor, and Sponsor masked trial.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Time to reach tumor progression</measure>
      <time_frame>52 weeks</time_frame>
      <description>Tumor Progression</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to composite endpoint</measure>
      <time_frame>52 weeks</time_frame>
      <description>Tumor progression or visual acuity failure</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Choroidal Melanoma</condition>
    <condition>Indeterminate Lesions</condition>
    <condition>Uveal Melanoma</condition>
    <condition>Ocular Melanoma</condition>
    <arm_group>
      <arm_group_label>High dose bel-sar treatment arm &amp; laser application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>High dose of bel-sar + laser application</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low dose bel-sar treatment arm &amp; laser application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Low dose of bel-sar + laser application</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham control arm &amp; sham laser</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Sham dose + sham laser</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Belzupacap Sarotalocan</intervention_name>
      <description>Bel-sar via suprachoroidal administration followed by laser application.</description>
      <arm_group_label>High dose bel-sar treatment arm &amp; laser application</arm_group_label>
      <arm_group_label>Low dose bel-sar treatment arm &amp; laser application</arm_group_label>
      <other_name>AU-011</other_name>
      <other_name>Bel-sar</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Suprachoroidal Microinjector</intervention_name>
      <description>Suprachoroidal injection device</description>
      <arm_group_label>High dose bel-sar treatment arm &amp; laser application</arm_group_label>
      <arm_group_label>Low dose bel-sar treatment arm &amp; laser application</arm_group_label>
      <other_name>SCS Microinjector</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Infrared Laser</intervention_name>
      <description>Laser application</description>
      <arm_group_label>High dose bel-sar treatment arm &amp; laser application</arm_group_label>
      <arm_group_label>Low dose bel-sar treatment arm &amp; laser application</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham Infrared Laser</intervention_name>
      <description>Sham laser application</description>
      <arm_group_label>Sham control arm &amp; sham laser</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham Microinjector</intervention_name>
      <description>Sham injection device</description>
      <arm_group_label>Sham control arm &amp; sham laser</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sham Treatment</intervention_name>
      <description>Sham drug via sham injection followed by sham laser</description>
      <arm_group_label>Sham control arm &amp; sham laser</arm_group_label>
      <other_name>Placebo Vehicle</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)&#xD;
  &#xD;
            -  Have no evidence of metastatic disease confirmed by imaging&#xD;
  &#xD;
            -  Be treatment naive for IL/CM (subjects who received PDT may be eligible)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have known contraindications or sensitivities to the study drug or laser&#xD;
  &#xD;
            -  Active ocular infection or disease&#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>Medical Monitor</last_name>
      <role>Study Director</role>
      <affiliation>Aura Biosciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Medical Monitor</last_name>
      <phone>617-500-8864</phone>
      <email>clinical@aurabiosciences.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Retina Consultants of Alabama</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35233</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>UCSD Shiley Eye Institute, Jacobs Retina Center</name>
        <address>
          <city>La Jolla</city>
          <state>California</state>
          <zip>92093</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Stanford University School of Medicine</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94303</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Retinal Consultants Medical Group, Inc.</name>
        <address>
          <city>Sacramento</city>
          <state>California</state>
          <zip>95825</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Retina Associates of Florida, PA</name>
        <address>
          <city>Tampa</city>
          <state>Florida</state>
          <zip>33609</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Emory Eye Center</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Northwestern University</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60611</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>University of Illinois at Chicago</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Massachusetts Eye and Ear</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Ophthalmic Consultants of Boston</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02116</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>W.K. Kellogg Eye Center - University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48105</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Associated Retinal Consultants (ARC) P.C.</name>
        <address>
          <city>Royal Oak</city>
          <state>Michigan</state>
          <zip>48073</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>The Retina Institute</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63117</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Nebraska Medicine's Truhlsen Eye Institute</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68105</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>University of Rochester, Flaum Eye Institute</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14642</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Duke Eye Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27705</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Cole Eye Institute</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Dean McGee Eye Institute</name>
        <address>
          <city>Oklahoma City</city>
          <state>Oklahoma</state>
          <zip>73104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Thomas Jefferson University (TJU) - Wills Eye Institute</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </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>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>University of Tennessee Hamilton Eye Institute</name>
        <address>
          <city>Memphis</city>
          <state>Tennessee</state>
          <zip>38103</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Tennessee Retina, PC</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37203</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Austin Retina Associates</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78705</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Texas Retina Associates</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75231</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>UT, Southwestern Medical Center</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75390</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Retina Associates of South Texas, P.A.</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78240</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </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>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Retina Consultants of Texas</name>
        <address>
          <city>The Woodlands</city>
          <state>Texas</state>
          <zip>77401</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Retina Associates of Utah</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84107</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Vitreoretinal Associates of Washington</name>
        <address>
          <city>Bellevue</city>
          <state>Washington</state>
          <zip>98004</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>University of Washington Medical Center</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>University of Wisconsin Madison</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53705</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.aurabiosciences.com</url>
      <description>Aura Biosciences</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 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 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Uveal Melanoma</keyword>
    <keyword>Eye Cancer</keyword>
    <keyword>Ocular Melanoma</keyword>
    <keyword>Choroidal Melanoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Melanoma</mesh_term>
    </condition_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/NCT06007690
  org study id: AU-011-301
  nct id: NCT06007690
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  The primary objective is to determine the safety and efficacy of belzupacap sarotalocan
        (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or
        small choroidal melanoma (CM).
  This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to
        establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration
        in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug
        product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser
        photoactivation device.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Subject, Assessor, and Sponsor masked trial.
  measure: Time to reach tumor progression
  time frame: 52 weeks
  description: Tumor Progression
  measure: Time to composite endpoint
  time frame: 52 weeks
  description: Tumor progression or visual acuity failure
  arm group label: High dose bel-sar treatment arm & laser application
  arm group type: Experimental
  description: High dose of bel-sar + laser application
  arm group label: Low dose bel-sar treatment arm & laser application
  arm group type: Experimental
  description: Low dose of bel-sar + laser application
  arm group label: Sham control arm & sham laser
  arm group type: Sham Comparator
  description: Sham dose + sham laser
  intervention type: Drug
  intervention name: Belzupacap Sarotalocan
  description: Bel-sar via suprachoroidal administration followed by laser application.
  arm group label: High dose bel-sar treatment arm & laser application
  arm group label: Low dose bel-sar treatment arm & laser application
  other name: AU-011
  other name: Bel-sar
  intervention type: Device
  intervention name: Suprachoroidal Microinjector
  description: Suprachoroidal injection device
  arm group label: High dose bel-sar treatment arm & laser application
  arm group label: Low dose bel-sar treatment arm & laser application
  other name: SCS Microinjector
  intervention type: Device
  intervention name: Infrared Laser
  description: Laser application
  arm group label: High dose bel-sar treatment arm & laser application
  arm group label: Low dose bel-sar treatment arm & laser application
  intervention type: Device
  intervention name: Sham Infrared Laser
  description: Sham laser application
  arm group label: Sham control arm & sham laser
  intervention type: Device
  intervention name: Sham Microinjector
  description: Sham injection device
  arm group label: Sham control arm & sham laser
  intervention type: Drug
  intervention name: Sham Treatment
  description: Sham drug via sham injection followed by sham laser
  arm group label: Sham control arm & sham laser
  other name: Placebo Vehicle
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Medical Monitor
  role: Study Director
  affiliation: Aura Biosciences
  last name: Medical Monitor
  phone: 617-500-8864
  email: clinical@aurabiosciences.com
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  country: United States
  url: http://www.aurabiosciences.com
  description: Aura Biosciences
  responsible party type: Sponsor
  mesh term: Melanoma
  sharing ipd: No