CompletedPhase 4

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

Canada15 participantsStarted 2021-05-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Optic nerve head and macula perfusion

Timeframe: 4 months

Trial details

NCT IDNCT04846179

SponsorNova Scotia Health Authority

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Glaucoma trials