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

Primary Purpose

Normal Tension Glaucoma

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gingko Baloba

Placebo

About this trial

This is an interventional treatment trial for Normal Tension Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

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).

Sites / Locations

New York Eye and Ear Infirmary of Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gingko Biloba Extract

Placebo

Arm Description

Gingko Biloba Extract 240 mg.

Placebo Pill

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT03761992

First Posted

November 20, 2018

Last Updated

March 16, 2020

Sponsor

Robert Ritch, MD, LLC.

1. Study Identification

Unique Protocol Identification Number

NCT03761992

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 19, 2018 (Actual)

Primary Completion Date

November 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Robert Ritch, MD, LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Normal Tension Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Gingko baloba extract (GBE) versus placebo

Masking

ParticipantInvestigator

Masking Description

Neither the patient nor the investigator will know which treatment that the patient is receiving.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gingko Biloba Extract

Arm Type

Active Comparator

Arm Description

Gingko Biloba Extract 240 mg.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Pill

Intervention Type

Dietary Supplement

Intervention Name(s)

Gingko Baloba

Other Intervention Name(s)

240mg. Gingko Biloba

Intervention Description

Tablets

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Tablets

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Ritch, MD

Phone

212-477-7540

rritch@nyee.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Luis Silva MD, MD

Phone

212-477-7540

lsilva@nyee.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Ritch, MD

Organizational Affiliation

New York Eye and Ear Infirmary of mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Eye and Ear Infirmary of Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Ritch, MD

Phone

212-477-7540

rritch@nyee.edu

First Name & Middle Initial & Last Name & Degree

Luis Silva, MD

Phone

212-477-7540

lsilva@nyee.edu

12. IPD Sharing Statement

Citations:

PubMed Identifier

16488940

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.

Results Reference

background

PubMed Identifier

26886116

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.

Results Reference

background

PubMed Identifier

26720776

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.

Results Reference

background

PubMed Identifier

23742177

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.

Results Reference

background

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

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