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/NCT06003751</url>
    </required_header>
    <id_info>
      <org_study_id>PER001-202</org_study_id>
      <nct_id>NCT06003751</nct_id>
    </id_info>
    <brief_title>A Study of PER-001 in Participants With Diabetic Retinopathy</brief_title>
    <official_title>A Phase 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Perfuse Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Perfuse Therapeutics, Inc.</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 Phase 2a, randomized, single-masked (participant), sham controlled clinical study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This clinical study is a randomized, single-masked (participant) study to further investigate&#xD;
        the ocular and systemic safety and tolerability of the two dose levels of PER-001&#xD;
        Intravitreal Implants in participants with diabetic retinopathy. Participants who meet entry&#xD;
        criteria will be randomized to receive either dose of PER-001 or sham control. A total of&#xD;
        approximately 24 participants (12 in each Cohort, will be randomized).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">May 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Placebo sham</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Best-corrected Visual Acuity (BCVA)</measure>
      <time_frame>End of Study(Week 24)</time_frame>
      <description>Change in BCVA from Baseline at Week 24 using BETDRS or modified ETDRS chart (Charts 1, 2, and R as applicable) with standardized distance and lighting ill be used to calculate the LogMAR score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intraocular Pressure (IOP)</measure>
      <time_frame>End of Study(Week 24)</time_frame>
      <description>IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ocular Adverse events</measure>
      <time_frame>End of Study(Week 24)</time_frame>
      <description>Frequency, severity and timing of ocular adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Adverse events</measure>
      <time_frame>End of Study(Week 24)</time_frame>
      <description>Frequency, severity and timing of systemic adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Diabetic Retinopathy</condition>
    <arm_group>
      <arm_group_label>Phase 2 Cohort A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort A - Low Dose or Sham</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase 2 Cohort B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort B - High Dose or Sham</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PER-001 Intravitreal Implant - Low Dose</intervention_name>
      <description>PER-001 Low Dose Intravitreal Implant</description>
      <arm_group_label>Phase 2 Cohort A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PER-001 Intravitreal Implant - High Dose</intervention_name>
      <description>PER-001 High Dose Intravitreal Implant</description>
      <arm_group_label>Phase 2 Cohort B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PER-001 Intravitreal Implant - Sham</intervention_name>
      <description>PER-001 Intravitreal Sham</description>
      <arm_group_label>Phase 2 Cohort A</arm_group_label>
      <arm_group_label>Phase 2 Cohort B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must be ≥ 18 years of age at the time of signing the informed consent&#xD;
  &#xD;
            -  A negative pregnancy test for females of childbearing potential at Screening (serum)&#xD;
               and Day 1 (urine).&#xD;
  &#xD;
            -  Best-corrected visual acuity (BCVA) of ≥ 60 Early Treatment Diabetic Retinopathy Study&#xD;
               (ETDRS) letters (Snellen equivalent of 20/63 or better) at Screening in potentially&#xD;
               eligible eye(s) and prior to randomization at Day 1 in the study eye&#xD;
  &#xD;
            -  Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) (diabetic&#xD;
               retinopathy severity scale [DRSS] of 47 to 53) within the standard 7-field ETDRS.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hemoglobin A1c &gt;12%, or if HbA1c ≤12%, diabetes mellitus is uncontrolled in the&#xD;
               opinion of the investigator&#xD;
  &#xD;
            -  Any condition which, in the opinion of the investigator, would preclude the&#xD;
               participant's ability to comply with study requirements including completion of the&#xD;
               study (including but not limited to diagnosis of dementia, Alzheimer's, and/or other&#xD;
               neurological disease or physical incapacity)&#xD;
  &#xD;
            -  Females who are pregnant, nursing, or planning a pregnancy during the study&#xD;
  &#xD;
            -  Active cancer within past 12 months except for appropriately treated carcinoma in situ&#xD;
               of the cervix, non-melanoma skin carcinoma or prostate cancer&#xD;
  &#xD;
            -  Uncontrolled blood pressure (defined as systolic &gt;160 or diastolic &gt;95 mmHg while the&#xD;
               participant is sitting).&#xD;
  &#xD;
            -  Currently untreated diabetes mellitus or previously untreated participants who&#xD;
               initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1&#xD;
  &#xD;
            -  History of cerebrovascular accident or myocardial infarction within 6 months prior to&#xD;
               Day 1&#xD;
  &#xD;
            -  Uncontrolled atrial fibrillation&#xD;
  &#xD;
            -  Systemic anti-VEGF treatment within 4 months prior to Day 1&#xD;
  &#xD;
            -  Any significant media opacity which precludes clinical evaluation and imaging of the&#xD;
               retina&#xD;
  &#xD;
            -  Presence of centrally involved DME (within 500 μm of the foveal center) at Screening&#xD;
               and Day 1&#xD;
  &#xD;
            -  Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or&#xD;
               epiretinal membrane involving the fovea or disrupting the macular architecture&#xD;
  &#xD;
            -  Active rubeosis&#xD;
  &#xD;
            -  History of vitrectomy surgery or retinal detachment or macular hole (Stage 3 or 4)&#xD;
  &#xD;
            -  Uncomplicated cataract surgery within 3 months of Screening or yttrium-aluminum-&#xD;
               garnet capsulotomy (YAG) within 4 weeks of Screening&#xD;
  &#xD;
            -  Aphakia or absence of posterior capsule&#xD;
  &#xD;
            -  Evidence of uncontrolled glaucoma (intraocular pressure must be &lt; 25 mmHg) at&#xD;
               Screening&#xD;
  &#xD;
            -  History of recurrent infectious or inflammatory ocular disease&#xD;
  &#xD;
            -  Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis (Note: mild&#xD;
               blepharitis is permitted if stable)&#xD;
  &#xD;
            -  Any active uveitis and/or vitritis or history of idiopathic or autoimmune-associated&#xD;
               uveitis&#xD;
  &#xD;
            -  History of herpetic ocular diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Andrew Melie</last_name>
      <phone>415-294-8750</phone>
      <email>info@perfusetherapeutics.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Perfuse Therapeutics, Inc</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94158</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrew Melie</last_name>
        <phone>415-294-8750</phone>
        <email>info@perfusetherapeutics.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 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>
    <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>
    </condition_browse>
    <!-- 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/NCT06003751
  org study id: PER001-202
  nct id: NCT06003751
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.
  This clinical study is a randomized, single-masked (participant) study to further investigate
        the ocular and systemic safety and tolerability of the two dose levels of PER-001
        Intravitreal Implants in participants with diabetic retinopathy. Participants who meet entry
        criteria will be randomized to receive either dose of PER-001 or sham control. A total of
        approximately 24 participants (12 in each Cohort, will be randomized).
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Placebo sham
  measure: Best-corrected Visual Acuity (BCVA)
  time frame: End of Study(Week 24)
  description: Change in BCVA from Baseline at Week 24 using BETDRS or modified ETDRS chart (Charts 1, 2, and R as applicable) with standardized distance and lighting ill be used to calculate the LogMAR score
  measure: Intraocular Pressure (IOP)
  time frame: End of Study(Week 24)
  description: IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.
  measure: Ocular Adverse events
  time frame: End of Study(Week 24)
  description: Frequency, severity and timing of ocular adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants
  measure: Systemic Adverse events
  time frame: End of Study(Week 24)
  description: Frequency, severity and timing of systemic adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants
  arm group label: Phase 2 Cohort A
  arm group type: Experimental
  description: Cohort A - Low Dose or Sham
  arm group label: Phase 2 Cohort B
  arm group type: Experimental
  description: Cohort B - High Dose or Sham
  intervention type: Drug
  intervention name: PER-001 Intravitreal Implant - Low Dose
  description: PER-001 Low Dose Intravitreal Implant
  arm group label: Phase 2 Cohort A
  intervention type: Drug
  intervention name: PER-001 Intravitreal Implant - High Dose
  description: PER-001 High Dose Intravitreal Implant
  arm group label: Phase 2 Cohort B
  intervention type: Drug
  intervention name: PER-001 Intravitreal Implant - Sham
  description: PER-001 Intravitreal Sham
  arm group label: Phase 2 Cohort A
  arm group label: Phase 2 Cohort B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Andrew Melie
  phone: 415-294-8750
  email: info@perfusetherapeutics.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Retinal Diseases
  mesh term: Diabetic Retinopathy