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Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTG

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ClinicalTrials.gov Identifier: NCT03761992
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Ritch, MD, LLC.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Normal Tension Glaucoma Dietary Supplement: Gingko Baloba Other: Placebo Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Gingko baloba extract (GBE) versus placebo
Masking: Double (Participant, Investigator)
Masking Description: Neither the patient nor the investigator will know which treatment that the patient is receiving.
Primary Purpose: Treatment
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
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Gingko Biloba Extract
Gingko Biloba Extract 240 mg.
Dietary Supplement: Gingko Baloba
Tablets
Other Name: 240mg. Gingko Biloba

Placebo Comparator: Placebo
Placebo Pill
Other: Placebo
Tablets




Primary Outcome Measures :
  1. Primary Outcome - Measure of Blood Vessel by Optical Cohrence Tomography Angiography (OCTA) [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Secondary Outcome - Measure of Blood Flow and Velocity by Nailfold Capillaroscopy (NFC) [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female of any race, at least 18 years of age

  • Has provided verbal and written informed consent.
  • Able and willing to follow instructions, including participation in all study assessments and visits.
  • Eyes with NTG will be enrolled.
  • Glaucoma severity will be graded using the WHO (World Health Organization)staging system.

NTG diagnosis will be based on the following:

  1. Glaucomatous optic disc on slit-lamp biomicroscopy defined as cup-to-disc ratio greater than 0.7, inter-eye asymmetry in cup-to-disc ration greater than 0.2 or neuroretinal rim notching, focal thinning, disc hemorrhage or vertical elongation of optic disc.
  2. Glaucomatous visual field defects on at least three reliable visual field examinations as measured by a glaucoma hemifield test (GHT) result outside normal limits and/or the appearance of at least three consecutive test points on the pattern deviation plot with p<1% and at least one at p<0.05%, not including points on the edge of the field.
  3. NTG will be defined as those subjects with a history of untreated peak IOP ≤21 mmHg.

    • Both eyes will be enrolled

Exclusion Criteria:

  • Best-corrected visual acuity less than 20/40
  • Age younger than 18 years or older than 80 years
  • Refractive error greater than +3.00 diopters (D) or less than -7.00 diopters (D)
  • Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation
  • Any other diseases that may cause visual field loss or optic disc abnormalities
  • Inability to perform reliably on automated visual field testing.
  • Subjects taking any GBE product will be washed out for 2 weeks prior to enrollment.
  • Diabetes.
  • Seizure disorder.
  • Taking any drugs that may interact with GBE (as listed).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761992


Contacts
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Contact: Robert Ritch, MD 212-477-7540 rritch@nyee.edu
Contact: Luis Silva MD, MD 212-477-7540 lsilva@nyee.edu

Locations
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United States, New York
New York Eye and Ear Infirmary of Mount Sinai Recruiting
New York, New York, United States, 10003
Contact: Robert Ritch, MD    212-477-7540    rritch@nyee.edu   
Contact: Luis Silva, MD    212-477-7540    lsilva@nyee.edu   
Sponsors and Collaborators
Robert Ritch, MD, LLC.
Investigators
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Principal Investigator: Robert Ritch, MD New York Eye and Ear Infirmary of mount Sinai

Publications:
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Responsible Party: Robert Ritch, MD, LLC.
ClinicalTrials.gov Identifier: NCT03761992     History of Changes
Other Study ID Numbers: NFC Gingko
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases