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

• ClinicalTrials.gov Identifier: NCT03761992
• Recruitment Status: Unknown
• First Posted: December 3, 2018
• Last Update Posted: March 17, 2020
• Sponsor: Robert Ritch, MD, LLC.
• Information provided by (Responsible Party): Robert Ritch, MD, LLC.

Study Description

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).

Study Design

• 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 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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 85 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).

Contacts and Locations

Contacts

Contact: Robert Ritch, MD; 212-477-7540; rritch@nyee.edu

Contact: Luis Silva MD, MD; 212-477-7540; lsilva@nyee.edu

Locations

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

• Principal Investigator: Robert Ritch, MD; New York Eye and Ear Infirmary of mount Sinai

More Information

Publications:

Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7.

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. Review.

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. Review.

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.

• Responsible Party: Robert Ritch, MD, LLC.
• ClinicalTrials.gov Identifier: NCT03761992
• Other Study ID Numbers: NFC Gingko
• First Posted: December 3, 2018
• Last Update Posted: March 17, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glaucoma; Low Tension Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases