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

NCT04846179 | Completed Phase 4

• 1 other identifier: 1026588
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Glaucoma

Keywords

Ginkgo biloba extract; Ocular perfusion; Optical coherence tomography angiography

Outcome Measures

Primary Outcomes (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

  4 months

Study Arms (1)

Ginkgo biloba extract group

EXPERIMENTAL

Group receiving ginkgo biloba extract supplementation

Dietary Supplement: Ginkgo biloba extract

Interventions

Ginkgo biloba extract DIETARY_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.

Ginkgo biloba extract group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B3H 4R2, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: May 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)