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GlaucomaPhase 4GBENCT04846179

To Evaluate the Effect of Ginkgo Biloba Extract on Optic Nerve Head Perfusion Examined Using OCTA

A Phase 4 study testing Ginkgo biloba extract in people with Glaucoma, run by Nova Scotia Health Authority at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Glaucoma is defined as progressive neuropathy of the optic nerve. It is an important cause of irreversible blindness worldwide. Lowering the intraocular pressure is the only proven treatment for this neurodegenerative disease. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Glaucoma
What is being tested?
Ginkgo biloba extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
1 May 2021to 31 Mar 2024
Phase
Phase 4
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Early open angle glaucoma based on gonioscopy, clinical assessment of optic nerve head, OCT optic nerve and Humphrey Visual Field 24-2 (MD < -10dB) and positive Glaucoma Hemifield Test
  • BCVA equal or better than 6/12
  • Written consent
  • Ability to comply with treatment intervention for duration of study

Who cannot join

  • Younger than 18 years of age
  • Angle closure glaucoma or secondary open angle glaucoma
  • Refraction exceeding 6D spherical equivalent or 3D astigmatism
  • Severe corneal, lens, vitreous media opacity limit signal strength of OCTA imaging
  • Severe open angle glaucoma with visual field mean deviation worse than -10dB
  • Inability to comply to treatment intervention (e.g. swallowing difficulty)
Show all 13Show fewer
  • History of ocular disease affecting ocular perfusion (e.g. CRAO, CRVO, diabetic retinopathy, ocular ischemic syndrome, ischemic optic neuropathy)
  • History of glaucoma surgery
  • Those taking anticoagulant therapy
  • Those with blood disorders or diabetes
  • Women who were pregnant, planning to become pregnant, or who were breast-feeding,
  • Patients with a history of seizures or who were currently taking anti-convulsant medication, and
  • Taking any drugs that may interact with GBE

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Nova Scotia Health

    Halifax, Nova Scotia, B3H 4R2

Other trials in Canada

About this study

Official title: To Evaluate the Effect of Ginkgo Biloba Extract on Optic Nerve Head Perfusion

Glaucoma is defined as progressive neuropathy of the optic nerve. It is an important cause of irreversible blindness worldwide. Lowering the intraocular pressure is the only proven treatment for this neurodegenerative disease. However, there is ongoing research looking at another modifiable risk factor that affects the development and progression of this disease. Ginkgo biloba (Ginkgoacease) is a tree species that has been used in traditional medicine for several hundred years to treat various diseases include improving vascular perfusion. We propose a study examining the effect of Ginkgo biloba extract supplementation on ocular perfusion using optical coherence tomography angiography.

Read the detailed description

Glaucoma is defined as progressive neuropathy of the optic nerve. It is an important cause of irreversible blindness worldwide. Lowering the intraocular pressure is the only proven treatment for this neurodegenerative disease. However, there is ongoing research looking at another modifiable risk factor that affects the development and progression of this disease. There is growing evidence that vascular dysfunction plays a role in the pathogenesis of glaucoma. Low ocular perfusion pressure (OPP), which is expressed as the difference between mean arterial pressure and intraocular pressure (IOP), has been hypothesized to lead to glaucomatous optic neuropathy via ischemic damage to the optic nerve. The Barbados Eye Study showed that reduced OPP at baseline was associated with a three-fold increased risk of glaucoma development. Evidence has also shown that optic nerve hypoperfusion may contribute to the progression of glaucoma.

Ginkgo biloba (Ginkgoacease) is a tree species that has been used in traditional medicine for several hundred years to treat various diseases. There have been recent studies that have examined its medicinal properties in treating age-related cognitive disease and neuronal degeneration resulting from ischaemic events. Studies examining systemic vascular ischemic diseases have shown a beneficial effect of ginkgo Biloba extract (GBE) on systemic arterial occlusive diseases. There is also preliminary research examining the effect GBE has on optic nerve head perfusion in patients with glaucoma. There is a study that examined the effects of antioxidants including GBE on ocular blood flow in patients with glaucoma using doppler ultrasound. When compared with patients receiving placebo, patients after antioxidant therapy containing GBE were shown to have increased peak systolic and/or end-diastolic blood velocities in all retrobulbar blood vessels, reduced vascular resistance in the central retinal and nasal short posterior ciliary arteries, increased superior and inferior temporal retinal capillary mean blood flow, an increased ratio of active to nonactive retinal capillaries. In the area of optic nerve head perfusion studies, fluorescein angiography has also been used in investigating alteration in blood flow in glaucomatous versus normal eyes. However, utility in clinical practice is limited by the qualitative nature of the test and the risk for adverse events. While color Doppler ultrasound is greatly limited in terms of resolution and can be openly used to examine large vessels of the eye. New development in ocular imaging has shown that OCTA can provide reproducible and quantifiable information about the microvasculature of the optic nerve and peripapillary retina in patients with glaucoma and can do so in a rapid and non-invasive manner avoiding some of the limitations on doppler ultrasound and fluorescein angiography.

GBE Egb761 is a standardized GBE that's used in most published research on the effect of ginkgo Biloba. It is a standardized GBE used in evidence-based medicine and clinical investigations ensuring clinical standardization and a safe manufacturing process. It has much of the toxic ginkgolic acid removed leaving behind the active components of flavonoid glycosides and terpene lactones. In general, GBE is well tolerated with a low side effect profile. Several systematic reviews on research using GBE (daily dose of up to 600 mg) report no statistical difference in side effects with GBE compared with placebo. There have been some concerns regarding the bleeding risk while on ginkgo supplementation. However, randomized placebo-controlled studies in healthy volunteers have not shown any changes in bleeding time, coagulation parameters, or platelet function. Multiple studies have reported minimal adverse effects (AEs) of GBE within a specific prescribed dosage range. Overall, GBE continues to be a well-tolerated supplement with a low side effect profile. Systematic reviews of the Cochrane databases, PubMed/MEDLINE, EMBASE, and Google Scholar, report no statistically significant difference in AEs between 80 and 600 mg of GBE and placebo.

Conditions
Glaucoma
Being tested
Ginkgo biloba extract
Keywords
Ginkgo biloba extract, Ocular perfusion, Optical coherence tomography angiography
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ginkgo biloba extractDietary supplement

    Patients recruited to Ginkgo Biloba Extract (GBE) group will be advised to take Webber Natural Ginkgo Biloba 120 mg soft gel, 1 tablet twice a day for 4 months.

Study groups in NCT04846179
Study groupRoleWhat they receive
Ginkgo biloba extract groupExperimentalGroup receiving ginkgo biloba extract supplementation
Receives: Dietary Supplement: Ginkgo biloba extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optic nerve head and macula perfusion

    Optic nerve head and macula perfusion will be analyzed using optical coherence tomography angiography after 4 months of ginkgo biloba extract supplementation

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2021
  2. Study start1 May 2021
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04846179
Sponsor's protocol ID
1026588
Acronym
GBE
Status last verified
Aug 2024
First submitted
12 Apr 2021
Last updated
21 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ginkgo biloba extract in people with Glaucoma, run by Nova Scotia Health Authority at 1 site in Canada.

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 5 inclusion and 13 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: finished, as of the sponsor's last update on 21 Aug 2024. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optic nerve head and macula perfusion (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Aug 2024.

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