<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/NCT04401982</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00086248</org_study_id>
    <nct_id>NCT04401982</nct_id>
  </id_info>
  <brief_title>Measuring the Effects of Rhopressa on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects</brief_title>
  <official_title>Measuring the Effects of Rhopressa on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects Using Erythrocyte Mediated Angiography In Vivo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aerie Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and&#xD;
      decreasing episcleral venous pressure. While this may result in improved episcleral venous&#xD;
      flow, current methods to quantify episcleral blood flow in vivo are rudimentary and unable to&#xD;
      accurately and precisely determine flow. Proof that Rhopressa effectively increases&#xD;
      episcleral venous flow would differentiate it from other medications. Furthermore, this&#xD;
      evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive&#xD;
      Glaucoma Surgery (MIGS) procedures. In future studies, MIGS procedures could be used to&#xD;
      improve the proximal outflow pathway, and Rhopressa to enhance distal outflow.&#xD;
&#xD;
      Specific Aim:&#xD;
&#xD;
      To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a&#xD;
      cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1&#xD;
      hour and 1 week after initiation of therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Need/Relevance:&#xD;
&#xD;
      Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and&#xD;
      decreasing episcleral venous pressure. While this may result in improved episcleral venous&#xD;
      flow, current methods to quantify episcleral blood flow in vivo are rudimentary and unable to&#xD;
      accurately and precisely determine flow. Proof that Rhopressa effectively increases&#xD;
      episcleral venous flow would differentiate it from other medications. Furthermore, this&#xD;
      evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive&#xD;
      Glaucoma Surgery (MIGS) procedures. In future studies, MIGS procedures could be used to&#xD;
      improve the proximal outflow pathway, and Rhopressa to enhance distal outflow.&#xD;
&#xD;
      Purpose/Aim:&#xD;
&#xD;
      The investigators have developed a technology to accurately and precisely determine&#xD;
      episcleral and retinal blood flow in human subjects using ICG labeled erythrocytes via a&#xD;
      technique the investigators have coined as Erythrocyte Mediated Angiography (EMA). The&#xD;
      investigators propose conducting a pilot study to show the effect of Rhopressa on both&#xD;
      improving episcleral blood flow as well as studying its effect on retinal blood flow. With&#xD;
      lower intraocular pressure, and correspondingly higher ocular perfusion pressure, Rhopressa&#xD;
      may also improve retinal blood flow.&#xD;
&#xD;
      Specific Aim:&#xD;
&#xD;
      To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a&#xD;
      cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1&#xD;
      hour and 1 week after initiation of therapy.&#xD;
&#xD;
      To test this hypothesis, the investigators will measure and compare episcleral venous and&#xD;
      retinal blood flow at baseline, 1 hour after Rhopressa instillation and 1 week after&#xD;
      initiation of Rhopressa.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2021</start_date>
  <completion_date type="Actual">February 22, 2022</completion_date>
  <primary_completion_date type="Actual">February 22, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in episcleral venous blood flow with Rhopressa</measure>
    <time_frame>1 year</time_frame>
    <description>Change in episcleral venous blood flow with Rhopressa as measured using erythrocyte mediated angiography flowmetry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in retinal blood flow in arterioles and venules less than 100 microns with Rhopressa</measure>
    <time_frame>1 year</time_frame>
    <description>Change in retinal blood flow in arterioles and venules less than 100 microns with Rhopressa. Retinal blood flow will be measured with erythrocyte mediated angiography flowmetry</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Ocular Hypertension</condition>
  <condition>Suspect Glaucoma</condition>
  <arm_group>
    <arm_group_label>Glaucoma Suspect</arm_group_label>
    <description>Individuals with a diagnosis of glaucoma suspect</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks</intervention_name>
    <description>Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks will be administered</description>
    <arm_group_label>Glaucoma Suspect</arm_group_label>
    <other_name>Rhopressa</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the optometry service and the glaucoma division at the&#xD;
        University of Maryland School of Medicine, Department of Ophthalmology. We will establish a&#xD;
        cohort of 10 patients comprised of treatment-naïve ocular hypertensive and glaucoma suspect&#xD;
        patients with the following eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at least 18 years of age.&#xD;
&#xD;
          -  Patients must have ocular hypertension or be a glaucoma suspect.&#xD;
&#xD;
          -  Patients must be treatment naïve without alternative study treatments or previous&#xD;
             history of using topical IOP lowering agents.&#xD;
&#xD;
          -  Patients must have an IOP of 24-30 mm Hg in the affected eye.&#xD;
&#xD;
          -  Patients must have open angles on gonioscopy.&#xD;
&#xD;
          -  Patients must be willing and able to comply with the protocol including providing&#xD;
             informed consent.&#xD;
&#xD;
          -  All patients will have at least one recorded visual field examination within 6 months&#xD;
             of enrollment in the study. Visual fields will be assessed using the&#xD;
             Hodapp-Andersen-Parish criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior intraocular surgery other than uncomplicated cataract surgery.&#xD;
&#xD;
          -  Allergy or history of adverse reaction to ICG, shellfish, or Iodine.&#xD;
&#xD;
          -  Significant liver disease or uremia.&#xD;
&#xD;
          -  Secondary glaucoma including exfoliation glaucoma, pigmentary glaucoma, or history of&#xD;
             acute angle closure.&#xD;
&#xD;
          -  Greater than 6 diopters of refractive error.&#xD;
&#xD;
          -  Moderate or severe visual field deficits as per Hodapp-Anderson-Parish criteria.&#xD;
&#xD;
          -  Any condition precluding imaging including reliable visual fields, disc photography,&#xD;
             or use of study treatments including media opacity or tilted optic disk.&#xD;
&#xD;
          -  Pregnant or nursing patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>88 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Osamah Saeedi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, Baltimore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Physicians Inc.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UM Faculty Physicians, Inc. | 5900 Waterloo Crossing</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Eye Consultants and Surgeons</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Osamah Saeedi</investigator_full_name>
    <investigator_title>Associate Professor; Glaucoma Division Chief; Director of Clinical Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Ocular Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04401982
org study id: HP-00086248
nct id: NCT04401982
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and
      decreasing episcleral venous pressure. While this may result in improved episcleral venous
      flow, current methods to quantify episcleral blood flow in vivo are rudimentary and unable to
      accurately and precisely determine flow. Proof that Rhopressa effectively increases
      episcleral venous flow would differentiate it from other medications. Furthermore, this
      evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive
      Glaucoma Surgery (MIGS) procedures. In future studies, MIGS procedures could be used to
      improve the proximal outflow pathway, and Rhopressa to enhance distal outflow.

      Specific Aim:

      To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a
      cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients.

      Hypothesis:

      Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1
      hour and 1 week after initiation of therapy.
Need/Relevance:

      Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and
      decreasing episcleral venous pressure. While this may result in improved episcleral venous
      flow, current methods to quantify episcleral blood flow in vivo are rudimentary and unable to
      accurately and precisely determine flow. Proof that Rhopressa effectively increases
      episcleral venous flow would differentiate it from other medications. Furthermore, this
      evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive
      Glaucoma Surgery (MIGS) procedures. In future studies, MIGS procedures could be used to
      improve the proximal outflow pathway, and Rhopressa to enhance distal outflow.

      Purpose/Aim:

      The investigators have developed a technology to accurately and precisely determine
      episcleral and retinal blood flow in human subjects using ICG labeled erythrocytes via a
      technique the investigators have coined as Erythrocyte Mediated Angiography (EMA). The
      investigators propose conducting a pilot study to show the effect of Rhopressa on both
      improving episcleral blood flow as well as studying its effect on retinal blood flow. With
      lower intraocular pressure, and correspondingly higher ocular perfusion pressure, Rhopressa
      may also improve retinal blood flow.

      Specific Aim:

      To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a
      cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients.

      Hypothesis:

      Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1
      hour and 1 week after initiation of therapy.

      To test this hypothesis, the investigators will measure and compare episcleral venous and
      retinal blood flow at baseline, 1 hour after Rhopressa instillation and 1 week after
      initiation of Rhopressa.
observational model: Cohort
time perspective: Prospective
measure: Change in episcleral venous blood flow with Rhopressa
time frame: 1 year
description: Change in episcleral venous blood flow with Rhopressa as measured using erythrocyte mediated angiography flowmetry.
measure: Change in retinal blood flow in arterioles and venules less than 100 microns with Rhopressa
time frame: 1 year
description: Change in retinal blood flow in arterioles and venules less than 100 microns with Rhopressa. Retinal blood flow will be measured with erythrocyte mediated angiography flowmetry
arm group label: Glaucoma Suspect
description: Individuals with a diagnosis of glaucoma suspect
intervention type: Drug
intervention name: Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks
description: Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks will be administered
arm group label: Glaucoma Suspect
other name: Rhopressa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 88 Years
last name: Osamah Saeedi, MD
role: Principal Investigator
affiliation: University of Maryland, Baltimore
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Osamah Saeedi
investigator title: Associate Professor; Glaucoma Division Chief; Director of Clinical Research
mesh term: Glaucoma
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Ophthalmic Solutions