Normal Tension GlaucomaNCT03761992
Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTG
A study testing Gingko Baloba in people with Normal Tension Glaucoma, run by Robert Ritch, MD, LLC. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Tension Glaucoma
- What is being tested?
- Gingko Baloba
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
Robert Ritch, MD, 212-477-7540, rritch@nyee.edu
Luis Silva, MD, 212-477-7540, lsilva@nyee.edu
About this study
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
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).
Read the 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).
- Conditions
- Normal Tension Glaucoma
- Being tested
- Gingko Baloba, Placebo
- Medical subject headings
- Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingko BalobaDietary supplement
Also called 240mg. Gingko Biloba
Tablets
PlaceboOther
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Gingko Biloba Extract | Active comparator | Gingko Biloba Extract 240 mg. Receives: Dietary Supplement: Gingko Baloba |
| Placebo | Placebo comparator | Placebo Pill Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start19 Nov 2018
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Gingko baloba extract (GBE) versus placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Ritch, MD, LLC.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Ritch, MD, Principal investigator, New York Eye and Ear Infirmary of mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761992
- Sponsor's protocol ID
- NFC Gingko
- Status last verified
- Mar 2020
- First submitted
- 20 Nov 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 16488940Kim 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.
PubMed 26886116Pasquale LR. Vascular and autonomic dysregulation in primary open-angle glaucoma. Curr Opin Ophthalmol. 2016 Mar;27(2):94-101. doi: 10.1097/ICU.0000000000000245.
PubMed 26720776Flammer 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.
PubMed 23742177
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03761992
- Acronym / sponsor ID
- NFC Gingko
- Conditions
- Normal Tension Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Robert Ritch, MD, LLC.University, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Gingko baloba extract (GBE) versus placebo
| Arm | Type | Receives |
|---|---|---|
| Gingko Biloba Extract | Active comparator | Dietary Supplement: Gingko BalobaGingko Biloba Extract 240 mg. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingko BalobaAlso: 240mg. Gingko BilobaTablets | Dietary supplement | Gingko Biloba Extract |
| PlaceboTablets | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Secondary Outcome - Measure of Blood Flow and Velocity by Nailfold Capillaroscopy (NFC)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 16488940Quigley 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.
- Background: PubMed 26886116Kim 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.
- Background: PubMed 26720776Pasquale LR. Vascular and autonomic dysregulation in primary open-angle glaucoma. Curr Opin Ophthalmol. 2016 Mar;27(2):94-101. doi: 10.1097/ICU.0000000000000245.
- Background: PubMed 23742177Flammer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Ritch, MD principal investigator
New York Eye and Ear Infirmary of mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingko Baloba in people with Normal Tension Glaucoma, run by Robert Ritch, MD, LLC. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Ritch, MD (212-477-7540, rritch@nyee.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome - Measure of Blood Vessel by Optical Cohrence Tomography Angiography (OCTA) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761992, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.