<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/NCT04424290</url>
  </required_header>
  <id_info>
    <org_study_id>1436-0001</org_study_id>
    <secondary_id>2019-004432-28</secondary_id>
    <nct_id>NCT04424290</nct_id>
  </id_info>
  <brief_title>HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia</brief_title>
  <acronym>HORNBILL</acronym>
  <official_title>A First-in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal dOses (Open Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of Multiple intravitReal Dosing (Single-masked, raNdomized, Sham-controlled) of BI 764524 in panretinaL Photocoagulation (PRP) Treated proLiferative Diabetic Retinopathy (PDR) Patients With Diabetic Macular Ischemia (DMI) - the HORNBILL Study</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 is a study in people with a type of diabetic eye disease called diabetic retinopathy&#xD;
      with diabetic macular ischemia. People who have had laser treatment for their diabetic&#xD;
      retinopathy can participate in the study. The laser treatment is called panretinal&#xD;
      photocoagulation.&#xD;
&#xD;
      The purpose of the study is to find out how well different doses of a medicine called BI&#xD;
      764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first&#xD;
      part, participants get different doses of BI 764524 only once. Participants are in the first&#xD;
      part for about 5 months and visit the study site about 8 times. In the second part,&#xD;
      participants are put into different groups by chance. Some participants get BI 764524&#xD;
      injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham&#xD;
      injection means that it is not a real injection and contains no medicine. Participants cannot&#xD;
      tell whether they get the real injection or a sham injection. For the second part,&#xD;
      participants are in the study for about 7 months. During this time, they visit the study site&#xD;
      about 7 times. In this study, BI 764524 is given to humans for the first time.&#xD;
&#xD;
      The doctors compare how well people tolerate the BI 764524 injections and the sham&#xD;
      injections.&#xD;
&#xD;
      The doctors also regularly check the general health of the participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">April 28, 2023</completion_date>
  <primary_completion_date type="Actual">April 28, 2023</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>This trial will consist of an single rising dose (SRD) part followed by an multiple dosing (MD) part. SRD part will be nonrandomized, open-label, and uncontrolled. MD part will be single-masked, randomized and sham-controlled (Ratio 2:1). Parties masked in the MD part are participant and masked site staff (including investigator). The Intervention model in the MD part is active group versus sham injection (=2 arms).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Single rising dose (SRD) part: Number of participants with dose limiting events</measure>
    <time_frame>14 weeks</time_frame>
    <description>Number of patients with dose limiting events (DLEs) from drug administration till day 8 (7 days after treatment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multiple dosing (MD) part: Number of patients with drug related adverse events (AEs) from drug administration till end of study (EOS)</measure>
    <time_frame>22 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>SRD part: Number of patients with drug related AEs at EOS</measure>
    <time_frame>14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SRD part: Number of patients with ocular AEs (eye disorders) at EOS</measure>
    <time_frame>14 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial and combined vascular complex at Visit 5</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of the size of the FAZ in OCTA in superficial and combined vascular complex at Visit 7</measure>
    <time_frame>22 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of best corrected visual acuity (BCVA) at Visit 3</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of BCVA at Visit 4</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of BCVA at Visit 5</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of BCVA at Visit 6</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of BCVA at Visit 7</measure>
    <time_frame>22 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 3</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 4</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 5</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 6</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 7</measure>
    <time_frame>22 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD part: Number of patients with ocular AEs at EOS</measure>
    <time_frame>22 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>SRD part: BI 764524</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SRD part: BI 764524</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MRD part: Sham control of BI 764524</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>MRD part: Sham control of BI 764524</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MRD part: BI 764524</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRD part: BI 764524</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 764524</intervention_name>
    <description>BI 764524</description>
    <arm_group_label>MRD part: BI 764524</arm_group_label>
    <arm_group_label>SRD part: BI 764524</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sham control of BI 764524</intervention_name>
    <description>Sham control of BI 764524</description>
    <arm_group_label>MRD part: Sham control of BI 764524</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Single rising dose (SRD) and multiple dosing (MD) part:&#xD;
&#xD;
          -  Pan-retinal photo coagulation treated proliferative diabetic retinopathy (PDR)&#xD;
             participants with either no or inactive retinal neovascularization per investigator&#xD;
             judgement in the study eye&#xD;
&#xD;
          -  Male or female participants of age ≥ 18 years&#xD;
&#xD;
          -  HbA1c of ≤ 12.0%&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) and men able to father a child must be ready&#xD;
             and able to use two methods of contraception with at least one of them being a highly&#xD;
             effective methods of birth control per ICH M3 (R2) that result in a low failure rate&#xD;
             of less than 1% per year when used consistently and correctly. A list of contraception&#xD;
             methods meeting these criteria is provided in the patient information and in the&#xD;
             clinical trial protocol.&#xD;
&#xD;
             --A woman is considered of childbearing potential (WOCBP), i.e. fertile, following&#xD;
             menarche and until becoming postmenopausal unless permanently sterile. Permanent&#xD;
             sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral&#xD;
             oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A&#xD;
             postmenopausal state is defined as no menses for 2 years without an alternative&#xD;
             medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal&#xD;
             range may be used to confirm a post-menopausal state in women not using hormonal&#xD;
             contraception or hormonal replacement therapy. However in the absence of 2 years of&#xD;
             menorrhea, a single FSH measurement is sufficient.&#xD;
&#xD;
          -  Signed and dated written informed consent in accordance with ICH Harmonized Guideline&#xD;
             for Good Clinical Practice (ICH GCP) and local legislation prior to admission to the&#xD;
             trial&#xD;
&#xD;
        SRD part only:&#xD;
&#xD;
          -  Evidence of diabetic macular ischemia (DMI) per investigator´s judgement, defined as&#xD;
             any degree of disruption of retinal vascularity in superficial and/or deep retinal&#xD;
             plexus in OCTA&#xD;
&#xD;
          -  Best-corrected Visual activity (VA) in the non-study eye better than best-corrected VA&#xD;
             in the study-eye, if both eyes are eligible and have identical VA the investigator may&#xD;
             select the study eye.&#xD;
&#xD;
          -  Best-corrected VA ≤55 letters (20/80) or worse&#xD;
&#xD;
        MD part only:&#xD;
&#xD;
          -  Presence of significant DMI: large foveal avascular zone defined as those with ≥0.5mm2&#xD;
             area in superficial vascular complex (SVC) present on optical coherence tomography&#xD;
             angiography. If FAZ is &lt;0.5mm2 then enlarged peri-foveal inter-capillary space in at&#xD;
             least 1 quadrant will be sufficient.&#xD;
&#xD;
          -  If both eyes are eligible, the investigator may select either eye to be the study eye.&#xD;
&#xD;
          -  Best-corrected VA ≤ 85 letters (20/20) or worse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        SRD part only:&#xD;
&#xD;
          -  Participants receiving intravitreal (IVT) injections for active diabetic macular edema&#xD;
             (DME, injections: anti-vascular endothelial growth factor (VEGF), steroids) and&#xD;
             macular laser in the study eye in the previous 3 months prior to enrolment&#xD;
&#xD;
          -  Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the&#xD;
             previous 3 months prior to enrolment&#xD;
&#xD;
          -  Current or planned use of medications known to be toxic to the retina, lens or optic&#xD;
             nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine,&#xD;
             phenothiazines, tamoxifen, nicotinic acid, and ethambutol)&#xD;
&#xD;
          -  Additional eye disease in the study eye that could compromise best corrected VA (BCVA)&#xD;
             with visual field loss, uncontrolled glaucoma (IOP&gt;24), age related macular&#xD;
             degeneration, history of ischemic optic neuropathy or retinal vascular occlusion,&#xD;
             symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa;&#xD;
             history of high myopia &gt; 8 diopters in the study eye. Anterior segment and vitreous&#xD;
             abnormalities in the study eye that would preclude adequate observation with SD-OCT&#xD;
&#xD;
          -  Any intraocular surgery in the study eye within 3 months prior to screening&#xD;
&#xD;
          -  Aphakia or total absence of the posterior capsule. Yttrium aluminium garnet (YAG)&#xD;
             laser capsulotomy in the study eye if performed less than 3 months prior to enrolment&#xD;
&#xD;
          -  Participants not expected to comply with the protocol requirements or not expected to&#xD;
             complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other&#xD;
             condition that, in the investigator´s opinion, makes the patient an unreliable trial&#xD;
             participant)&#xD;
&#xD;
          -  Previous participation in this trial or in other trials with IVT injections&#xD;
             administered within 3 months.&#xD;
&#xD;
        Further exclusion criteria apply.&#xD;
&#xD;
        MD part only:&#xD;
&#xD;
          -  DME, defined as a central subfield thickness (CST) ≥305 micrometer (μm) for men and&#xD;
             ≥290 μm women measured with optovue (Optical coherent tomography) OCT in the study eye&#xD;
&#xD;
          -  Participants receiving IVT injections for active DME (anti-VEGF, steroids) and macular&#xD;
             laser in the study eye in the previous 3 months prior to enrolment&#xD;
&#xD;
          -  Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the&#xD;
             previous 3 months prior to enrolment&#xD;
&#xD;
          -  Heavily lasered macula in the study eye per investigator's judgement&#xD;
&#xD;
          -  History of vitrectomy in the study eye&#xD;
&#xD;
          -  Epiretinal membrane with extended foveal contour distortion in the study eye per&#xD;
             investigator's judgement&#xD;
&#xD;
          -  Current or planned use of medications known to be toxic to the retina, lens or optic&#xD;
             nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine,&#xD;
             phenothiazines, tamoxifen, nicotinic acid, and ethambutol) Further exclusion criteria&#xD;
             apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Trinity Research</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina-Vitreous Associates Medical Group</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Retina Institute</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raj K. Maturi, MD PC</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Vitreoretinal Consultants</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Eye and Ear Infirmary of Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Research Center for Retina, PLLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Texas</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Retina Institute, PA</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Texas</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Royal Infirmary</name>
      <address>
        <city>Bradford</city>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Eye Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS1 2LX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southend University Hospital</name>
      <address>
        <city>Essex</city>
        <zip>SS0 0RY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Royal Hospital</name>
      <address>
        <city>Gloucester</city>
        <zip>GL1 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moorfields Eye Hospital</name>
      <address>
        <city>London</city>
        <zip>EC1V 2PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunderland Eye Infirmary</name>
      <address>
        <city>Sunderland</city>
        <zip>SR2 9HP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <disposition_first_submitted>July 11, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>July 11, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 13, 2023</disposition_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 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>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Ischemia</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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: https://www.mystudywindow.com/msw/datasharing</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/NCT04424290
org study id: 1436-0001
secondary id: 2019-004432-28
nct id: NCT04424290
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a study in people with a type of diabetic eye disease called diabetic retinopathy
      with diabetic macular ischemia. People who have had laser treatment for their diabetic
      retinopathy can participate in the study. The laser treatment is called panretinal
      photocoagulation.

      The purpose of the study is to find out how well different doses of a medicine called BI
      764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first
      part, participants get different doses of BI 764524 only once. Participants are in the first
      part for about 5 months and visit the study site about 8 times. In the second part,
      participants are put into different groups by chance. Some participants get BI 764524
      injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham
      injection means that it is not a real injection and contains no medicine. Participants cannot
      tell whether they get the real injection or a sham injection. For the second part,
      participants are in the study for about 7 months. During this time, they visit the study site
      about 7 times. In this study, BI 764524 is given to humans for the first time.

      The doctors compare how well people tolerate the BI 764524 injections and the sham
      injections.

      The doctors also regularly check the general health of the participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: This trial will consist of an single rising dose (SRD) part followed by an multiple dosing (MD) part. SRD part will be nonrandomized, open-label, and uncontrolled. MD part will be single-masked, randomized and sham-controlled (Ratio 2:1). Parties masked in the MD part are participant and masked site staff (including investigator). The Intervention model in the MD part is active group versus sham injection (=2 arms).
measure: Single rising dose (SRD) part: Number of participants with dose limiting events
time frame: 14 weeks
description: Number of patients with dose limiting events (DLEs) from drug administration till day 8 (7 days after treatment).
measure: Multiple dosing (MD) part: Number of patients with drug related adverse events (AEs) from drug administration till end of study (EOS)
time frame: 22 weeks
measure: SRD part: Number of patients with drug related AEs at EOS
time frame: 14 weeks
measure: SRD part: Number of patients with ocular AEs (eye disorders) at EOS
time frame: 14 weeks
measure: MD part: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial and combined vascular complex at Visit 5
time frame: 12 weeks
measure: MD part: Change from baseline of the size of the FAZ in OCTA in superficial and combined vascular complex at Visit 7
time frame: 22 weeks
measure: MD part: Change from baseline of best corrected visual acuity (BCVA) at Visit 3
time frame: 4 weeks
measure: MD part: Change from baseline of BCVA at Visit 4
time frame: 8 weeks
measure: MD part: Change from baseline of BCVA at Visit 5
time frame: 12 weeks
measure: MD part: Change from baseline of BCVA at Visit 6
time frame: 16 weeks
measure: MD part: Change from baseline of BCVA at Visit 7
time frame: 22 weeks
measure: MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 3
time frame: 4 weeks
measure: MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 4
time frame: 8 weeks
measure: MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 5
time frame: 12 weeks
measure: MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 6
time frame: 16 weeks
measure: MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 7
time frame: 22 weeks
measure: MD part: Number of patients with ocular AEs at EOS
time frame: 22 weeks
arm group label: SRD part: BI 764524
arm group type: Experimental
description: SRD part: BI 764524
arm group label: MRD part: Sham control of BI 764524
arm group type: Sham Comparator
description: MRD part: Sham control of BI 764524
arm group label: MRD part: BI 764524
arm group type: Experimental
description: MRD part: BI 764524
intervention type: Drug
intervention name: BI 764524
description: BI 764524
arm group label: MRD part: BI 764524
arm group label: SRD part: BI 764524
intervention type: Drug
intervention name: Sham control of BI 764524
description: Sham control of BI 764524
arm group label: MRD part: Sham control of BI 764524
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United Kingdom
country: United States
url: https://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Ischemia
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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: https://www.mystudywindow.com/msw/datasharing