<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/NCT03761992</url>
  </required_header>
  <id_info>
    <org_study_id>NFC Gingko</org_study_id>
    <nct_id>NCT03761992</nct_id>
  </id_info>
  <brief_title>Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTG</brief_title>
  <official_title>Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in Normaltension Glaucoma by Ocular Coherence Tomography Angiography and Nailfold Capillaroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Robert Ritch, MD, LLC.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Robert Ritch, MD, LLC.</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>
      The purpose of this study is to evaluate the effect of Ginkgo biloba extract (GBE) on the&#xD;
      number of blood vessels in the back of the eye as well as the amount of blood flow at the&#xD;
      nailfold(where the fingernail meets the skin) of the 4th finger in the hand.This finger,&#xD;
      along with the 5th finger, has the most transparent skin, which makes imaging a little&#xD;
      easier. GBE is an over-the-counter pill, made from a natural powder taken from the Gingko&#xD;
      (Maidenhair) tree, that is widely used. A technique called Optical Coherence Tomography&#xD;
      Angiography (OCTA),will be used to measure the small blood vessels at the back of the eye,&#xD;
      the macula (the area of sharpest vision), and the optic disc (the point at which the nerve&#xD;
      fibers from the retina enter to form the optic nerve, which transmits visual impulses to the&#xD;
      brain).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GBE has been reported to improve blood flow to the brain, eye, and extremeties(hands,&#xD;
      feet,etc.). .As with most supplements, GBE is neither regulated nor FDA approved.&#xD;
&#xD;
      A technique called Optical Coherence Tomography Angiography (OCTA),will be used to measure&#xD;
      the small blood vessels at the back of the eye, the macula (the area of sharpest vision), and&#xD;
      the optic disc (the point at which the nerve fibers from the retina enter to form the optic&#xD;
      nerve, which transmits visual impulses to the brain). This technique uses a camera, capable&#xD;
      of imaging the smallest vessels, so that their density (number) can be calculated by a&#xD;
      computer. This is being done to determine if there is disease causing increasing loss of&#xD;
      these vessels. The imaging is done by a widely used camera which does not contact the eye. It&#xD;
      simply uses visible light to measure the amount of blood vessels present in a determined area&#xD;
      in the back of the eye. Blood flow at the 4th finger nailfold (nailfold capillaroscopy; NFC)&#xD;
      is a standard technique, especially in rheumatology, performed by using a commercially&#xD;
      available light microscope which glides over the base of the fingernail and can image the&#xD;
      tiny capillaries in the nailfold. These images are recorded as videos from which the blood&#xD;
      flow can be analyzed by freely available software for the purpose of quantitative&#xD;
      measurements (amount of blood flow and blood flow velocity).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Gingko baloba extract (GBE) versus placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Neither the patient nor the investigator will know which treatment that the patient is receiving.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome - Measure of Blood Vessel by Optical Cohrence Tomography Angiography (OCTA)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The investigators plan to evaluate the density of the small blood vessels at the back of the eye. This will be measured by a OCTA. A camera capable of imaging the smallest vessels so that their density (number) can be calculated by a computer, the purpose being to determine if there is disease causing progressive loss of these vessels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Measure of Blood Flow and Velocity by Nailfold Capillaroscopy (NFC)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring blood flow at the 4th finger nailfold by NFC is a standard technique, especially in rheumatology, in which a commercially available light microscope glides over the base of the fingernail to image the tiny capillaries in the nailfold. These images are recorded as videos from which the blood flow can be analyzed quantitatively by freely available software to measure blood flow and velocity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Normal Tension Glaucoma</condition>
  <arm_group>
    <arm_group_label>Gingko Biloba Extract</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gingko Biloba Extract 240 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Pill</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Gingko Baloba</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Gingko Biloba Extract</arm_group_label>
    <other_name>240mg. Gingko Biloba</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male or female of any race, at least 18 years of age&#xD;
&#xD;
          -  Has provided verbal and written informed consent.&#xD;
&#xD;
          -  Able and willing to follow instructions, including participation in all study&#xD;
             assessments and visits.&#xD;
&#xD;
          -  Eyes with NTG will be enrolled.&#xD;
&#xD;
          -  Glaucoma severity will be graded using the WHO (World Health Organization)staging&#xD;
             system.&#xD;
&#xD;
        NTG diagnosis will be based on the following:&#xD;
&#xD;
          1. Glaucomatous optic disc on slit-lamp biomicroscopy defined as cup-to-disc ratio&#xD;
             greater than 0.7, inter-eye asymmetry in cup-to-disc ration greater than 0.2 or&#xD;
             neuroretinal rim notching, focal thinning, disc hemorrhage or vertical elongation of&#xD;
             optic disc.&#xD;
&#xD;
          2. Glaucomatous visual field defects on at least three reliable visual field examinations&#xD;
             as measured by a glaucoma hemifield test (GHT) result outside normal limits and/or the&#xD;
             appearance of at least three consecutive test points on the pattern deviation plot&#xD;
             with p&lt;1% and at least one at p&lt;0.05%, not including points on the edge of the field.&#xD;
&#xD;
          3. NTG will be defined as those subjects with a history of untreated peak IOP ≤21 mmHg.&#xD;
&#xD;
               -  Both eyes will be enrolled&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Best-corrected visual acuity less than 20/40&#xD;
&#xD;
          -  Age younger than 18 years or older than 85 years&#xD;
&#xD;
          -  Refractive error greater than +3.00 diopters (D) or less than -7.00 diopters (D)&#xD;
&#xD;
          -  Previous intraocular surgery except for uncomplicated cataract extraction with&#xD;
             posterior chamber intraocular lens implantation&#xD;
&#xD;
          -  Any other diseases that may cause visual field loss or optic disc abnormalities&#xD;
&#xD;
          -  Inability to perform reliably on automated visual field testing.&#xD;
&#xD;
          -  Subjects taking any GBE product will be washed out for 2 weeks prior to enrollment.&#xD;
&#xD;
          -  Diabetes.&#xD;
&#xD;
          -  Seizure disorder.&#xD;
&#xD;
          -  Taking any drugs that may interact with GBE (as listed).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Ritch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Eye and Ear Infirmary of mount Sinai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert Ritch, MD</last_name>
    <phone>212-477-7540</phone>
    <email>rritch@nyee.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luis Silva MD, MD</last_name>
    <phone>212-477-7540</phone>
    <email>lsilva@nyee.edu</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Ritch, MD</last_name>
      <phone>212-477-7540</phone>
      <email>rritch@nyee.edu</email>
    </contact>
    <contact_backup>
      <last_name>Luis Silva, MD</last_name>
      <phone>212-477-7540</phone>
      <email>lsilva@nyee.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.</citation>
    <PMID>16488940</PMID>
  </reference>
  <reference>
    <citation>Kim KE, Park KH. Update on the Prevalence, Etiology, Diagnosis, and Monitoring of Normal-Tension Glaucoma. Asia Pac J Ophthalmol (Phila). 2016 Jan-Feb;5(1):23-31. doi: 10.1097/APO.0000000000000177.</citation>
    <PMID>26886116</PMID>
  </reference>
  <reference>
    <citation>Pasquale LR. Vascular and autonomic dysregulation in primary open-angle glaucoma. Curr Opin Ophthalmol. 2016 Mar;27(2):94-101. doi: 10.1097/ICU.0000000000000245.</citation>
    <PMID>26720776</PMID>
  </reference>
  <reference>
    <citation>Flammer J, Konieczka K, Flammer AJ. The primary vascular dysregulation syndrome: implications for eye diseases. EPMA J. 2013 Jun 7;4(1):14. doi: 10.1186/1878-5085-4-14.</citation>
    <PMID>23742177</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</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>Glaucoma</mesh_term>
    <mesh_term>Low Tension Glaucoma</mesh_term>
  </condition_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/NCT03761992
org study id: NFC Gingko
nct id: NCT03761992
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of Ginkgo biloba extract (GBE) on the
      number of blood vessels in the back of the eye as well as the amount of blood flow at the
      nailfold(where the fingernail meets the skin) of the 4th finger in the hand.This finger,
      along with the 5th finger, has the most transparent skin, which makes imaging a little
      easier. GBE is an over-the-counter pill, made from a natural powder taken from the Gingko
      (Maidenhair) tree, that is widely used. A technique called Optical Coherence Tomography
      Angiography (OCTA),will be used to measure the small blood vessels at the back of the eye,
      the macula (the area of sharpest vision), and the optic disc (the point at which the nerve
      fibers from the retina enter to form the optic nerve, which transmits visual impulses to the
      brain).
GBE has been reported to improve blood flow to the brain, eye, and extremeties(hands,
      feet,etc.). .As with most supplements, GBE is neither regulated nor FDA approved.

      A technique called Optical Coherence Tomography Angiography (OCTA),will be used to measure
      the small blood vessels at the back of the eye, the macula (the area of sharpest vision), and
      the optic disc (the point at which the nerve fibers from the retina enter to form the optic
      nerve, which transmits visual impulses to the brain). This technique uses a camera, capable
      of imaging the smallest vessels, so that their density (number) can be calculated by a
      computer. This is being done to determine if there is disease causing increasing loss of
      these vessels. The imaging is done by a widely used camera which does not contact the eye. It
      simply uses visible light to measure the amount of blood vessels present in a determined area
      in the back of the eye. Blood flow at the 4th finger nailfold (nailfold capillaroscopy; NFC)
      is a standard technique, especially in rheumatology, performed by using a commercially
      available light microscope which glides over the base of the fingernail and can image the
      tiny capillaries in the nailfold. These images are recorded as videos from which the blood
      flow can be analyzed by freely available software for the purpose of quantitative
      measurements (amount of blood flow and blood flow velocity).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Gingko baloba extract (GBE) versus placebo
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Neither the patient nor the investigator will know which treatment that the patient is receiving.
measure: Primary Outcome - Measure of Blood Vessel by Optical Cohrence Tomography Angiography (OCTA)
time frame: 4 weeks
description: The investigators plan to evaluate the density of the small blood vessels at the back of the eye. This will be measured by a OCTA. A camera capable of imaging the smallest vessels so that their density (number) can be calculated by a computer, the purpose being to determine if there is disease causing progressive loss of these vessels.
measure: Secondary Outcome - Measure of Blood Flow and Velocity by Nailfold Capillaroscopy (NFC)
time frame: 4 weeks
description: Measuring blood flow at the 4th finger nailfold by NFC is a standard technique, especially in rheumatology, in which a commercially available light microscope glides over the base of the fingernail to image the tiny capillaries in the nailfold. These images are recorded as videos from which the blood flow can be analyzed quantitatively by freely available software to measure blood flow and velocity.
arm group label: Gingko Biloba Extract
arm group type: Active Comparator
description: Gingko Biloba Extract 240 mg.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Pill
intervention type: Dietary Supplement
intervention name: Gingko Baloba
description: Tablets
arm group label: Gingko Biloba Extract
other name: 240mg. Gingko Biloba
intervention type: Other
intervention name: Placebo
description: Tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Ritch, MD
role: Principal Investigator
affiliation: New York Eye and Ear Infirmary of mount Sinai
last name: Robert Ritch, MD
phone: 212-477-7540
email: rritch@nyee.edu
last name: Luis Silva MD, MD
phone: 212-477-7540
email: lsilva@nyee.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PMID: 16488940
citation: Kim KE, Park KH. Update on the Prevalence, Etiology, Diagnosis, and Monitoring of Normal-Tension Glaucoma. Asia Pac J Ophthalmol (Phila). 2016 Jan-Feb;5(1):23-31. doi: 10.1097/APO.0000000000000177.
PMID: 26886116
citation: Pasquale LR. Vascular and autonomic dysregulation in primary open-angle glaucoma. Curr Opin Ophthalmol. 2016 Mar;27(2):94-101. doi: 10.1097/ICU.0000000000000245.
PMID: 26720776
citation: Flammer J, Konieczka K, Flammer AJ. The primary vascular dysregulation syndrome: implications for eye diseases. EPMA J. 2013 Jun 7;4(1):14. doi: 10.1186/1878-5085-4-14.
PMID: 23742177
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Low Tension Glaucoma