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/NCT05986864</url>
    </required_header>
    <id_info>
      <org_study_id>SKG0106-101</org_study_id>
      <nct_id>NCT05986864</nct_id>
    </id_info>
    <brief_title>Phase I/II Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity, and Pharmacokinetics of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD)</brief_title>
    <official_title>A Multicenter, Open-label, Dose Escalation, Phase 1 Clinical Study and Randomized, Double-masked, Controlled, Dose Expansion Phase 2 Clinical Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity, and Pharmacokinetics of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Skyline Therapeutics (US) Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Skyline Therapeutics</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy,&#xD;
        immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD.&#xD;
        Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be&#xD;
        conducted.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2025</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>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety assessments</measure>
      <time_frame>52 Weeks</time_frame>
      <description>Safety assessments consist of collecting all AE, SAEs, AESIs, and clinically significant laboratory abnormalities for vital signs, physical examinations, ECGs, and clinical laboratory tests.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Best corrected visual acuity</measure>
      <time_frame>52 Weeks</time_frame>
      <description>Change in Best Corrected Visual Acuity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intraocular pressure</measure>
      <time_frame>52 Weeks</time_frame>
      <description>The same method of IOP measurement must be used for the same subject from screening through the Week 52 (EOS) visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Optical coherence tomography</measure>
      <time_frame>52 Weeks</time_frame>
      <description>SD-OCT will be performed to measure CSTQuestionnaire-25 (VFQ-25)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICGA</measure>
      <time_frame>52 Weeks</time_frame>
      <description>ICG will be performed in the study eye at screening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Function Questionnaire-25</measure>
      <time_frame>52 Weeks</time_frame>
      <description>visual function following treatment</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Neovascular Age-related Macular Degeneration</condition>
    <arm_group>
      <arm_group_label>Phase I: Low dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SKG0106 One-Time Intraocular Injection Dose Level 1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase I: Medium dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SKG0106 One-Time Intraocular Injection Dose Level 2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase I: High dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SKG0106 One-Time Intraocular Injection Dose Level 3</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>SKG0106</intervention_name>
      <description>SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product</description>
      <arm_group_label>Phase I: High dose</arm_group_label>
      <arm_group_label>Phase I: Low dose</arm_group_label>
      <arm_group_label>Phase I: Medium dose</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able&#xD;
               to complete the study as required by the protocol;&#xD;
  &#xD;
            2. Aged ≥ 50 years at screening;&#xD;
  &#xD;
               Study Eye:&#xD;
  &#xD;
            3. Diagnosis of nAMD as determined by the PI;&#xD;
  &#xD;
            4. Active CNV lesions secondary to age-related macular degeneration (AMD);&#xD;
  &#xD;
            5. Total CNV area (classical and occult) at screening must account for more than 50% of&#xD;
               the total lesion area in the study eye (confirmed by CRC at Phase 2 clinical study);&#xD;
  &#xD;
            6. Intraretinal and/or subretinal fluid in the fovea of the retina in the study eye,&#xD;
               confirmed by CRC at Phase 2 clinical study;&#xD;
  &#xD;
            7. BCVA between 63 and 19 letters (inclusive) in the study eye examined using the Early&#xD;
               Treatment of Diabetic Retinopathy Study testing at screening and baseline.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any active intraocular or periocular infection or active intraocular inflammation&#xD;
               (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious&#xD;
               blepharitis, uveitis) in the study eye at baseline;&#xD;
  &#xD;
            2. Results of colorful fundus photography assessment at screening showed fibrotic or&#xD;
               geographic atrophic changes in the fovea of retina in the study eye, confirmed by CRC&#xD;
               at Phase 2 clinical study;&#xD;
  &#xD;
            3. Retinal pigment epithelial tear in the study eye at screening;&#xD;
  &#xD;
            4. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within&#xD;
               4 weeks prior to baseline;&#xD;
  &#xD;
            5. Any condition that, in the opinion of the investigator, may limit visual acuity&#xD;
               improvement in the study eye (e.g., history of intraocular disease other than nAMD in&#xD;
               the study eye or current evidence of intraocular disease [including retinopathy] that,&#xD;
               in the judgment of the investigator, may require medical or surgical intervention to&#xD;
               prevent or treat visual acuity lost possibly caused by the condition or may limit the&#xD;
               possibility of increased visual acuity following study treatment);&#xD;
  &#xD;
            6. History of retinal detachment or active retinal detachment in the study eye;&#xD;
  &#xD;
            7. Any prior gene therapy.&#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_contact>
      <last_name>Yongqin Wang</last_name>
      <phone>+86 18616737445</phone>
      <email>yongqin.wang@skytx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Retina Consultants of Texas</name>
        <address>
          <city>Katy</city>
          <state>Texas</state>
          <zip>77494</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Marie Chin</last_name>
      </contact>
      <investigator>
        <last_name>Charles C Wykoff, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Wagner Kapoor Research Institute</name>
        <address>
          <city>Norfolk</city>
          <state>Virginia</state>
          <zip>23502</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Chris Riebling</last_name>
      </contact>
      <investigator>
        <last_name>Alan Wagner, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>AMD</keyword>
    <keyword>wet AMD</keyword>
    <keyword>wAMD</keyword>
    <keyword>nAMD</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>
    </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/NCT05986864
  org study id: SKG0106-101
  nct id: NCT05986864
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy,
        immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD.
        Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be
        conducted.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety assessments
  time frame: 52 Weeks
  description: Safety assessments consist of collecting all AE, SAEs, AESIs, and clinically significant laboratory abnormalities for vital signs, physical examinations, ECGs, and clinical laboratory tests.
  measure: Best corrected visual acuity
  time frame: 52 Weeks
  description: Change in Best Corrected Visual Acuity
  measure: Intraocular pressure
  time frame: 52 Weeks
  description: The same method of IOP measurement must be used for the same subject from screening through the Week 52 (EOS) visit.
  measure: Optical coherence tomography
  time frame: 52 Weeks
  description: SD-OCT will be performed to measure CSTQuestionnaire-25 (VFQ-25)
  measure: ICGA
  time frame: 52 Weeks
  description: ICG will be performed in the study eye at screening
  measure: Visual Function Questionnaire-25
  time frame: 52 Weeks
  description: visual function following treatment
  arm group label: Phase I: Low dose
  arm group type: Experimental
  description: SKG0106 One-Time Intraocular Injection Dose Level 1
  arm group label: Phase I: Medium dose
  arm group type: Experimental
  description: SKG0106 One-Time Intraocular Injection Dose Level 2
  arm group label: Phase I: High dose
  arm group type: Experimental
  description: SKG0106 One-Time Intraocular Injection Dose Level 3
  intervention type: Genetic
  intervention name: SKG0106
  description: SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
  arm group label: Phase I: High dose
  arm group label: Phase I: Low dose
  arm group label: Phase I: Medium dose
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yongqin Wang
  phone: +86 18616737445
  email: yongqin.wang@skytx.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Macular Degeneration
  mesh term: Wet Macular Degeneration
  sharing ipd: No