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/NCT05972473</url>
    </required_header>
    <id_info>
      <org_study_id>CIBI302A301CN</org_study_id>
      <nct_id>NCT05972473</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD</brief_title>
    <official_title>A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects With Neovascular Age-Related Macular Degeneration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Innovent Biologics (Suzhou) Co. Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is designed for multi-center,randomized,double-masked,active-contralled study to&#xD;
        evaluate effective and security of intravitreal injection of IBI302 in subjects with&#xD;
        neovascular age-related macular degeneration.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2027</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean change from baseline in BCVA score at Week 44, 48, and 52 for the study eye.</measure>
      <time_frame>At week 44, 48, 52</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16</measure>
      <time_frame>At week 16</time_frame>
      <description>The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in BCVA at Week 52 and 100</measure>
      <time_frame>Upto Week 100</time_frame>
      <description>Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100</measure>
      <time_frame>Upto Week 100</time_frame>
      <description>Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100</measure>
      <time_frame>Upto Week 100</time_frame>
      <description>the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100</measure>
      <time_frame>Upto Week 100</time_frame>
      <description>Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).</measure>
      <time_frame>Upto Week 100</time_frame>
      <description>All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Neovascular Age-related Macular Degeneration</condition>
    <arm_group>
      <arm_group_label>Aflibercept</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Drug: Aflibercept 2mg/eye; Intraocular injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IBI302 dose 8mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: IBI302 8mg/eye; Intraocular injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aflibercept Ophthalmic</intervention_name>
      <description>2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).</description>
      <arm_group_label>Aflibercept</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>IBI302</intervention_name>
      <description>8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.</description>
      <arm_group_label>IBI302 dose 8mg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed informed consent must be obtained prior to study participation;&#xD;
  &#xD;
            2. Male or female ≥ 50 years of age at the time of signing the informed consent;&#xD;
  &#xD;
            3. Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid&#xD;
               involving the fovea;&#xD;
  &#xD;
            4. BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Ocular disease: Any concurrent intraocular condition/systemic disease in the study eye at&#xD;
          screening or baseline that, in the judgment of the investigator, may cause the participant&#xD;
          fail to respond to the treatment or confuse the interpretation of study results; Total&#xD;
          lesion area(including blood, atrophy, fibrosis, PED and neovascularization)&gt; 12 optic disc&#xD;
          area (DA) on FFA; Subretinal hemorrhage area &gt; 50% of the total lesion area, or subretinal&#xD;
          hemorrhage area involving macular fovea ≥ 1 DA; Fibrosis or atrophy area &gt; 50% of the total&#xD;
          lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as&#xD;
          intraocular pressure ≥ 25 mmHg after standard treatment); Presence of active intraocular or&#xD;
          periocular infection or inflammation; Ocular treatment: Anti-VEGF or anti-complement&#xD;
          therapy in the study eye within 90 days prior to baseline; Fundus laser photo-coagulation&#xD;
          in the study eye within 90 days prior to baseline; Photodynamic Therapy (PDT) in the study&#xD;
          eye within 90 days prior to baseline; History of vitreoretinal surgery, penetrating&#xD;
          keratoplasty in the study eye; General condition or treatment: Uncontrolled hypertension&#xD;
          (defined as systolic blood pressure &gt; 160 mmHg or diastolic blood pressure &gt; 100 mmHg after&#xD;
          standard treatment); HbA1c &gt; 8% within 28 days prior to baseline; Systemic anti-VEGF drug&#xD;
          and anti-complement drug therapy within 90 days prior to baseline; History of&#xD;
          hypersensitivity to any component of the test article, control article, or clinically&#xD;
          relevant sensitivity to fluorescein dye, povidone-iodine; Pregnant or lactating women;&#xD;
          Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow&#xD;
          the trial protocol), as judged by the investig.&#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>Yating Liu</last_name>
      <phone>15821084695</phone>
      <email>yating.liu@innoventbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Innovent Biologics (Suzhou) Co,Ltd.</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215123</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yating Liu</last_name>
        <phone>15821084695</phone>
        <email>yating.liu@innoventbio.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</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 Degeneration</mesh_term>
      <mesh_term>Wet Macular Degeneration</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>
  
  
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/NCT05972473
  org study id: CIBI302A301CN
  nct id: NCT05972473
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is designed for multi-center,randomized,double-masked,active-contralled study to
        evaluate effective and security of intravitreal injection of IBI302 in subjects with
        neovascular age-related macular degeneration.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Mean change from baseline in BCVA score at Week 44, 48, and 52 for the study eye.
  time frame: At week 44, 48, 52
  measure: The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16
  time frame: At week 16
  description: The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter)
  measure: Change from baseline in BCVA at Week 52 and 100
  time frame: Upto Week 100
  description: Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
  measure: Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100
  time frame: Upto Week 100
  description: Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center.
  measure: Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100
  time frame: Upto Week 100
  description: the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA
  measure: Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100
  time frame: Upto Week 100
  description: Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit.
  measure: Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).
  time frame: Upto Week 100
  description: All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE.
  arm group label: Aflibercept
  arm group type: Active Comparator
  description: Drug: Aflibercept 2mg/eye; Intraocular injection
  arm group label: IBI302 dose 8mg
  arm group type: Experimental
  description: Drug: IBI302 8mg/eye; Intraocular injection
  intervention type: Drug
  intervention name: Aflibercept Ophthalmic
  description: 2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).
  arm group label: Aflibercept
  intervention type: Biological
  intervention name: IBI302
  description: 8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.
  arm group label: IBI302 dose 8mg
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yating Liu
  phone: 15821084695
  email: yating.liu@innoventbio.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Macular Degeneration
  mesh term: Wet Macular Degeneration
  mesh term: Aflibercept
  sharing ipd: No