Ginkgo Biloba and Ocular Blood Flow in Primary Open-angle Glaucoma

NCT02376114 | Completed Phase 2

• 1 other identifier: Ginkgo and blood flow
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Glaucoma is one of the leading causes of blindness. Ginkgo biloba may be part of an effective treatment strategy for glaucoma because it has been shown to improve blood flow, it has antioxidant properties, it can relax smooth muscle, and it can protect neurons from damage. The goal of our study was to determine whether Ginkgo biloba would result in increased ocular blood flow which may protect against glaucoma damage.

Conditions

Glaucoma, Open-Angle

Keywords

ocular blood flow; ginkgo biloba; glaucoma; vasospasm

Outcome Measures

Primary Outcomes (1)

• Change in optic nerve head blood flow in the rim region as measured with the Heidelberg Retinal Flowmeter

  Change in optic nerve head blood flow in the rim region as measured with the Heidelberg Retinal Flowmeter

  4 weeks and 10 weeks

Secondary Outcomes (4)

• Change in retinal blood flow as measured by the Canon Laser Blood Flowmeter

  4 weeks and 10 weeks

• Change in ocular pulse amplitude as measured with the Pascal Dynamic Contour Tonometer

  4 weeks and 10 weeks

• Change in peripheral vasospasm as measured during the cold provocation test using the Transonic Laser Doppler Flowmeter

  4 weeks and 10 weeks

• Change in endothelin-1 levels as measured by an enzyme-linked immunosorbent assay kit

  4 weeks and 10 weeks

Study Arms (2)

Ginkgo-Placebo

OTHER

Patients receive Ginkgo biloba and then placebo afterwards.

Drug: Ginkgo biloba

Placebo-Ginkgo

OTHER

Patients receive placebo and then Ginkgo biloba afterwards.

Drug: Placebo to Ginkgo biloba

Interventions

Ginkgo biloba DRUG

The Ginkgo biloba extract that was used contained 24% ginkgo flavone glycosides and 6% terpene lactones (Vitamin Research Products, Carson City, Nevada). Patients took 60 mg of Ginkgo or a placebo twice daily by mouth for two weeks. The placebo consisted of 40 mg of corn starch. Ginkgo and the placebo were encapsulated to ensure identical appearance.

Ginkgo-Placebo

Placebo to Ginkgo biloba DRUG

Placebo-Ginkgo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We focused this trial on vasospastic glaucoma patients because we believed that these would be the patients most likely to benefit from the ability of Ginkgo to improve blood flow.
• Patients who had been identified from previous research as being vasospastic on the Transonic Laser Doppler Flowmeter (Transonic Systems Inc., Ithaca, NY) were contacted and asked if they would like to participate in the trial.
• We recruited vasospastic patients with early or moderate primary open-angle glaucoma with a typical visual field defect with an abnormal Glaucoma Hemifield Test and a Mean Deviation worse than -2 decibels, and an optic nerve head showing retinal nerve fiber layer or neuroretinal rim loss characteristic of glaucoma.
• There was no restriction for intraocular pressure at time of diagnosis although at the time of recruitment intraocular pressure had to be effectively controlled either by ocular hypertension therapy or by surgery.
• If a patient had two eyes eligible, data from the right eye only was used.

You may not qualify if:

• 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
• those who could not return for 2 follow-up visits at 4 and 6 weeks.
• those patients who are already taking Ginkgo were asked if they were willing to stop for 6 weeks before the study.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Ginkgo Extract

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Ellen Freeman, PhD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

• Mark Lesk, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 3, 2015
• Study Start: August 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-02

Locations

CA (1)