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/NCT06006585</url>
    </required_header>
    <id_info>
      <org_study_id>1497-0001</org_study_id>
      <nct_id>NCT06006585</nct_id>
    </id_info>
    <brief_title>A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy</brief_title>
    <official_title>Safety, Tolerability, and Pharmacokinetics of Intravitreal Single Rising Doses and Multiple Doses of BI 771716 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boehringer Ingelheim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boehringer Ingelheim</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is open to adults with geographic atrophy, an advanced form of age-related macular&#xD;
        degeneration. People can join the study if they are at least 50 years old. The purpose of&#xD;
        this study is to find out how well different doses of a medicine called BI 771716 are&#xD;
        tolerated.&#xD;
  &#xD;
        This study has 2 parts. Part 1 of the study takes about 3 months. In this part, participants&#xD;
        receive 1 injection of BI 771716 directly into one of the eyes affected by geographic&#xD;
        atrophy.&#xD;
  &#xD;
        Part 2 of the study takes about 4 months. In this part, participants receive 2 injections of&#xD;
        BI 771716 directly into the eye. There are 4 weeks between the first and the second&#xD;
        injection. In this study, BI 771716 is given to humans for the first time.&#xD;
  &#xD;
        The doctors compare how well participants tolerate the different doses of BI 771716. The&#xD;
        doctors also regularly check the general health of the participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8</measure>
      <time_frame>Up to 7 days</time_frame>
      <description>SRD part</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS)</measure>
      <time_frame>Up to 112 days</time_frame>
      <description>MD part</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS</measure>
      <time_frame>Up to 112 days</time_frame>
      <description>SRD part</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax)</measure>
      <time_frame>Up to 84 days</time_frame>
      <description>SRD part</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
      <time_frame>Up to 84 days</time_frame>
      <description>SRD part</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from dosing to maximum serum concentration of BI 771716 (tmax)</measure>
      <time_frame>Up to 84 days</time_frame>
      <description>SRD part</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trough concentration of BI 771716 in serum</measure>
      <time_frame>At Day 29</time_frame>
      <description>MD part</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BI 771716 serum concentration</measure>
      <time_frame>At Day 57</time_frame>
      <description>MD part</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Geographic Atrophy</condition>
    <arm_group>
      <arm_group_label>BI 771716 low dose treatment group (Single rising dose (SRD part))</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 771716 treatment group (multiple dose (MD part))</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 771716 medium dose treatment group (SRD part)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BI 771716 high dose treatment group (SRD part)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BI 771716</intervention_name>
      <description>BI 771716</description>
      <arm_group_label>BI 771716 high dose treatment group (SRD part)</arm_group_label>
      <arm_group_label>BI 771716 low dose treatment group (Single rising dose (SRD part))</arm_group_label>
      <arm_group_label>BI 771716 medium dose treatment group (SRD part)</arm_group_label>
      <arm_group_label>BI 771716 treatment group (multiple dose (MD part))</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Men and women with geographic atrophy (GA) secondary to age-related macular&#xD;
               degeneration (AMD), with any GA lesion of minimum 1 disc diameter in size, and&#xD;
               unlimited maximum size. This may include GA lesions contiguous to or continuous with&#xD;
               peripapillary atrophy.&#xD;
  &#xD;
            2. Fellow eye is not required to have GA.&#xD;
  &#xD;
            3. Best corrected visual acuity (BCVA) in the non-study eye must have a better BCVA&#xD;
               compared to the study eye.&#xD;
  &#xD;
            4. BCVA of ≥4 and ≤70 letters in the study eye (approximate equivalent to 20/800 and&#xD;
               20/40 on the Snellen chart) measured by the Early Treatment Diabetic Retinopathy Study&#xD;
               (ETDRS) protocol.&#xD;
  &#xD;
            5. Age at least 50 years.&#xD;
  &#xD;
            6. Men able to father a child must be ready and able to use highly effective methods of&#xD;
               birth control per the International Council on Harmonisation of Technical Requirements&#xD;
               for Registration of Human Use guideline M3(R2) (ICH M3(R2)) that would result in a low&#xD;
               failure rate of less than 1% per year when used consistently and correctly.&#xD;
  &#xD;
            7. Signed informed consent consistent with ICH good clinical practice (GCP) guidelines&#xD;
               and local legislation prior to participation in the trial, which includes medication&#xD;
               washout and restrictions.&#xD;
  &#xD;
            8. Not under any administrative or legal supervision or under institutionalization due to&#xD;
               regulatory or juridical order.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Women of childbearing potential (WOCBP) cannot be included. A woman is considered of&#xD;
               childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming&#xD;
               post-menopausal unless permanently sterile. Permanent sterilization methods include&#xD;
               hysterectomy, bilateral salpingectomy and bilateral oophorectomy or another cause as&#xD;
               determined by the investigator (e.g. Müllerian agenesis). Tubal ligation is NOT a&#xD;
               method of permanent sterilization. A postmenopausal state is defined as no menses for&#xD;
               1 year without an alternative medical cause.&#xD;
  &#xD;
            2. History of or evidence of current active exudative choroidal neovascularization (CNV)&#xD;
               in the study eye. History of evidence of exudative CNV in the fellow eye is not&#xD;
               exclusionary. Eyes with evidence of non-exudative CNV are not exclusionary (as&#xD;
               identified by Optical coherence tomography angiography (OCT-A) or Indocyanine green&#xD;
               angiography (ICG-A)).&#xD;
  &#xD;
            3. Previously received treatment in the study eye for GA secondary to AMD within 3 months&#xD;
               prior to screening.&#xD;
  &#xD;
            4. Previous trial participation receiving trial medication for GA in the study eye&#xD;
               secondary to AMD within 6 months prior to screening. Use of any investigational drug&#xD;
               within 90 days or 5 half-lives prior to screening, whichever is longer.&#xD;
  &#xD;
            5. Previously received gene therapy or cell therapy.&#xD;
  &#xD;
            6. Additional eye disease in the study eye that could compromise trial participation:&#xD;
  &#xD;
                 1. uncontrolled glaucoma or intraocular pressure &gt;24 mmHg.&#xD;
  &#xD;
                 2. clinically significant diabetic maculopathy.&#xD;
  &#xD;
                 3. history of high myopia &gt;8 diopters in the study eye.&#xD;
  &#xD;
                 4. anterior segment and vitreous abnormalities in the study eye that would preclude&#xD;
                    adequate observation with Spectral domain optical coherence tomography (SD-OCT).&#xD;
  &#xD;
                 5. exclude ocular conditions at discretion of BI that might interfere with outcome&#xD;
                    of the trial.&#xD;
  &#xD;
            7. Exclude prior vitrectomy surgery.&#xD;
  &#xD;
            8. Exclude study eyes that have undergone glaucoma drainage implantation or&#xD;
               trabeculectomy. History of microinvasive glaucoma surgery may be included.&#xD;
  &#xD;
          Further exclusion criteria apply.&#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>Boehringer Ingelheim</last_name>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </overall_contact>
    <link>
      <url>http://www.mystudywindow.com</url>
      <description>Related Info</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 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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>Geographic Atrophy</mesh_term>
      <mesh_term>Atrophy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
  For more details refer to:&#xD;
  https://www.mystudywindow.com/msw/datatransparency</ipd_description>
    </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/NCT06006585
  org study id: 1497-0001
  nct id: NCT06006585
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This study is open to adults with geographic atrophy, an advanced form of age-related macular
        degeneration. People can join the study if they are at least 50 years old. The purpose of
        this study is to find out how well different doses of a medicine called BI 771716 are
        tolerated.
  
        This study has 2 parts. Part 1 of the study takes about 3 months. In this part, participants
        receive 1 injection of BI 771716 directly into one of the eyes affected by geographic
        atrophy.
  
        Part 2 of the study takes about 4 months. In this part, participants receive 2 injections of
        BI 771716 directly into the eye. There are 4 weeks between the first and the second
        injection. In this study, BI 771716 is given to humans for the first time.
  
        The doctors compare how well participants tolerate the different doses of BI 771716. The
        doctors also regularly check the general health of the participants.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8
  time frame: Up to 7 days
  description: SRD part
  measure: Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS)
  time frame: Up to 112 days
  description: MD part
  measure: Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS
  time frame: Up to 112 days
  description: SRD part
  measure: Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax)
  time frame: Up to 84 days
  description: SRD part
  measure: Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
  time frame: Up to 84 days
  description: SRD part
  measure: Time from dosing to maximum serum concentration of BI 771716 (tmax)
  time frame: Up to 84 days
  description: SRD part
  measure: Trough concentration of BI 771716 in serum
  time frame: At Day 29
  description: MD part
  measure: BI 771716 serum concentration
  time frame: At Day 57
  description: MD part
  arm group label: BI 771716 low dose treatment group (Single rising dose (SRD part))
  arm group type: Experimental
  arm group label: BI 771716 treatment group (multiple dose (MD part))
  arm group type: Experimental
  arm group label: BI 771716 medium dose treatment group (SRD part)
  arm group type: Experimental
  arm group label: BI 771716 high dose treatment group (SRD part)
  arm group type: Experimental
  intervention type: Drug
  intervention name: BI 771716
  description: BI 771716
  arm group label: BI 771716 high dose treatment group (SRD part)
  arm group label: BI 771716 low dose treatment group (Single rising dose (SRD part))
  arm group label: BI 771716 medium dose treatment group (SRD part)
  arm group label: BI 771716 treatment group (multiple dose (MD part))
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  url: http://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Macular Degeneration
  mesh term: Geographic Atrophy
  mesh term: Atrophy
  sharing ipd: No
  ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
  For more details refer to:
  https://www.mystudywindow.com/msw/datatransparency