- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761992
Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTG
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Ritch, MD
- Phone Number: 212-477-7540
- Email: rritch@nyee.edu
Study Contact Backup
- Name: Luis Silva MD, MD
- Phone Number: 212-477-7540
- Email: lsilva@nyee.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- New York Eye and Ear Infirmary of Mount Sinai
-
Contact:
- Robert Ritch, MD
- Phone Number: 212-477-7540
- Email: rritch@nyee.edu
-
Contact:
- Luis Silva, MD
- Phone Number: 212-477-7540
- Email: lsilva@nyee.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gingko Biloba Extract
Gingko Biloba Extract 240 mg.
|
Tablets
Other Names:
|
Placebo Comparator: Placebo
Placebo Pill
|
Tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Ritch, MD, New York Eye and Ear Infirmary of Mount Sinai
Publications and helpful links
General 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. doi: 10.1136/bjo.2005.081224.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFC Gingko
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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