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

NCT03761992 | Unknown

• 1 other identifier: NFC Gingko
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Normal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

• Primary Outcome - Measure of Blood Vessel by Optical Cohrence Tomography Angiography (OCTA)

  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.

  4 weeks

Secondary Outcomes (1)

• Secondary Outcome - Measure of Blood Flow and Velocity by Nailfold Capillaroscopy (NFC)

  4 weeks

Study Arms (2)

Gingko Biloba Extract

ACTIVE COMPARATOR

Gingko Biloba Extract 240 mg.

Dietary Supplement: Gingko Baloba

Placebo

PLACEBO COMPARATOR

Placebo Pill

Other: Placebo

Interventions

Gingko Baloba DIETARY_SUPPLEMENT

Tablets

Also known as: 240mg. Gingko Biloba

Gingko Biloba Extract

Placebo OTHER

Tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.
• NTG will be defined as those subjects with a history of untreated peak IOP ≤21 mmHg.
• Both eyes will be enrolled

You may not qualify if:

• 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).

Sponsors & Collaborators

• Robert Ritch, MD, LLC.: lead

Study Sites (1)

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Robert Ritch, MD

  New York Eye and Ear Infirmary of mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Ritch, MD

CONTACT

212-477-7540; rritch@nyee.edu

Luis Silva MD, MD

CONTACT

212-477-7540; lsilva@nyee.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the patient nor the investigator will know which treatment that the patient is receiving.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Gingko baloba extract (GBE) versus placebo

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 3, 2018
• Study Start: November 19, 2018
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

US (1)