Recruiting

Gingko Biloba

Sponsor:

Robert Ritch, MD, LLC.

Code:

NCT03761992

Conditions

Normal Tension Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gingko Baloba

Placebo

Study Details

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

Study ID

NCT03761992

Start date

Nov 19, 2018

Status verified date

Mar, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Nov, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Gingko Biloba Extract

Gingko Biloba Extract 240 mg.

placebo comparator: Placebo

Placebo Pill

Interventions

Gingko Baloba

Tablets

Placebo

Tablets

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

New York Eye and Ear Infirmary of Mount Sinai

Recruiting

New York, New York, United States, 10003

Contacts

More Information

Sponsor

Robert Ritch, MD, LLC.

Last update posted

Mar 17, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert Ritch, MD, LLC. on 2020-03-17.