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/NCT06015633</url>
    </required_header>
    <id_info>
      <org_study_id>OC-2301TV</org_study_id>
      <nct_id>NCT06015633</nct_id>
    </id_info>
    <brief_title>Ocular, Vascular, and Genetic Findings in AMD Patients</brief_title>
    <official_title>Exploration of Ocular, Vascular, and Genetic Findings Associated and Correlated With the Presence of Late-stage AMD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>OcuDyne, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>OcuDyne, Inc.</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>
        Observation of findings associated with AMD&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Explorational observation of ocular, vascular, and genetic findings in patients diagnosed&#xD;
        with AMD&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>OCT-A</measure>
      <time_frame>Baseline observation of incidence / correlation only</time_frame>
      <description>OCT-A metrics in subjects with AMD</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Genetic markers related to AMD</measure>
      <time_frame>Baseline observation of incidence / correlation only</time_frame>
      <description>Presence of 52 known AMD related genetic markers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Magnetic Resonance Angiography</measure>
      <time_frame>Baseline observation of incidence / correlation only</time_frame>
      <description>Ophthalmic artery MRI / MRA results in subjects with AMD</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Age-Related Macular Degeneration</condition>
    <arm_group>
      <arm_group_label>Exudative AMD</arm_group_label>
      <description>Subjects that have at least one eye with a history of, or active, exudative age related macular degeneration</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-exudative AMD</arm_group_label>
      <description>Subjects that have at least one eye with late stage non-exudative age-related macular degeneration (presence of geographic atrophy)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>Observational only</description>
      <arm_group_label>Exudative AMD</arm_group_label>
      <arm_group_label>Non-exudative AMD</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects with exudative or non-exudative late-stage age-related macular degeneration.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. At least 55 years of age at the time of consent&#xD;
  &#xD;
            2. Able to understand and provide written informed consent&#xD;
  &#xD;
            3. Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to&#xD;
               permit quality fundus imaging&#xD;
  &#xD;
            4. Able to cooperate with ophthalmic visual function testing and anatomic assessments&#xD;
  &#xD;
            5. Diagnosed with late-stage AMD in at least one eye. (if both eyes of an eligible&#xD;
               subject meet inclusion criterion, the more advanced eye will receive primary eye&#xD;
               assignment)&#xD;
  &#xD;
            6. Willing to have protocol specified genetic testing&#xD;
  &#xD;
            7. Willing to have head coil MRI/A (with contrast if deemed necessary)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Ocular&#xD;
  &#xD;
            1. History of any retinal disease other than AMD in either eye&#xD;
  &#xD;
            2. Spherical equivalent refractive error demonstrating &gt;6 diopters of myopia or an axial&#xD;
               length &gt;26 mm in the study eye&#xD;
  &#xD;
            3. History of vitrectomy in the study eye&#xD;
  &#xD;
            4. Any intraocular surgery (including lens replacement surgery) in the study eye, within&#xD;
               90 days of enrollment&#xD;
  &#xD;
            5. History of endophthalmitis&#xD;
  &#xD;
            6. Trabeculectomy or aqueous shunt or valve in the study eye&#xD;
  &#xD;
            7. Aphakia or absence of the posterior capsule in the study eye (Note: Previous violation&#xD;
               of the posterior capsule is also excluded unless it occurred as a result of yttrium&#xD;
               aluminum garnet [YAG] laser posterior capsulotomy in association with prior posterior&#xD;
               chamber intraocular lens implantation and at least 90 days prior to enrollment)&#xD;
  &#xD;
            8. Presence of advanced guttae or visually significant keratopathy that would cause&#xD;
               scattering of light or alter visual function in the study eye&#xD;
  &#xD;
            9. History of idiopathic or autoimmune-associated uveitis in either eye&#xD;
  &#xD;
           10. Active inflammation or infection, including conjunctivitis, keratitis, or scleritis in&#xD;
               either eye&#xD;
  &#xD;
           11. GA secondary to a condition other than AMD (e.g., Stargardt's disease, cone rod&#xD;
               dystrophy, or toxic maculopathies such as Plaquenil maculopathy) in either eye&#xD;
  &#xD;
               Non-Ocular&#xD;
  &#xD;
           12. Use of any investigational product or investigational medical device (i.e., not&#xD;
               approved by FDA for the specific use) within 90 days prior to screening or anticipated&#xD;
               use during the study&#xD;
  &#xD;
           13. Women of childbearing potential who are pregnant or unwilling to use effective&#xD;
               contraception for the duration of the study&#xD;
  &#xD;
           14. Acute or serious illness, in the opinion of the site investigator&#xD;
  &#xD;
           15. History of kidney failure or gadolinium toxicity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Luana Wilbur, BS</last_name>
      <role>Study Director</role>
      <affiliation>OcuDyne VP, Clinical and Regulatory Affairs</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Luana Wilbur, BS</last_name>
      <phone>01-858-442-7178</phone>
      <email>lwilbur@ocudyne.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tel Aviv Sourasky Medical Center</name>
        <address>
          <city>Tel Aviv</city>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Omer Trivizki, MD</last_name>
        <phone>054 2400775</phone>
        <email>omert@tlvmc.gov.il</email>
      </contact>
      <contact_backup>
        <last_name>Daniela McLeod</last_name>
        <email>danielaml@tlvmc.gov.il</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 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>
    </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/NCT06015633
  org study id: OC-2301TV
  nct id: NCT06015633
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Observation of findings associated with AMD
  Explorational observation of ocular, vascular, and genetic findings in patients diagnosed
        with AMD
  observational model: Cohort
  time perspective: Other
  measure: OCT-A
  time frame: Baseline observation of incidence / correlation only
  description: OCT-A metrics in subjects with AMD
  measure: Genetic markers related to AMD
  time frame: Baseline observation of incidence / correlation only
  description: Presence of 52 known AMD related genetic markers
  measure: Magnetic Resonance Angiography
  time frame: Baseline observation of incidence / correlation only
  description: Ophthalmic artery MRI / MRA results in subjects with AMD
  arm group label: Exudative AMD
  description: Subjects that have at least one eye with a history of, or active, exudative age related macular degeneration
  arm group label: Non-exudative AMD
  description: Subjects that have at least one eye with late stage non-exudative age-related macular degeneration (presence of geographic atrophy)
  intervention type: Other
  intervention name: No intervention
  description: Observational only
  arm group label: Exudative AMD
  arm group label: Non-exudative AMD
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Luana Wilbur, BS
  role: Study Director
  affiliation: OcuDyne VP, Clinical and Regulatory Affairs
  last name: Luana Wilbur, BS
  phone: 01-858-442-7178
  email: lwilbur@ocudyne.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Macular Degeneration
  sharing ipd: No