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NCT04846179CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
15 (actual)
First submitted
12 Apr 2021
Start date
1 May 2021
Primary completion date
31 Mar 2024
Lead sponsor
Nova Scotia Health Authority
Diseases
Glaucoma
NCT number
NCT04846179

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 15
  • From 1 May 2021 to the primary completion date, 31 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Those taking anticoagulant therapy
  • Patients with a history of seizures or who were currently taking anti-convulsant medication, and
  • Taking any drugs that may interact with GBE

Other illness

  • History of ocular disease affecting ocular perfusion (e.g. CRAO, CRVO, diabetic retinopathy, ocular ischemic syndrome, ischemic optic neuropathy)
  • History of glaucoma surgery
  • Those with blood disorders or diabetes

Age

  • Younger than 18 years of age

Other

  • 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)
  • Women who were pregnant, planning to become pregnant, or who were breast-feeding,

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nova Scotia Health
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.