Ginkgo Biloba and Ocular Blood Flow in Primary Open-angle Glaucoma
Primary Purpose
Glaucoma, Open-Angle
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Ginkgo biloba
Placebo to Ginkgo biloba
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring ocular blood flow, ginkgo biloba, glaucoma, vasospasm
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Maisonneuve-Rosemont Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Ginkgo-Placebo
Placebo-Ginkgo
Arm Description
Patients receive Ginkgo biloba and then placebo afterwards.
Patients receive placebo and then Ginkgo biloba afterwards.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in retinal blood flow as measured by the Canon Laser Blood Flowmeter
Change in retinal blood flow as measured by the Canon Laser Blood Flowmeter
Change in ocular pulse amplitude as measured with the Pascal Dynamic Contour Tonometer
Change in ocular pulse amplitude as measured with the Pascal Dynamic Contour Tonometer
Change in peripheral vasospasm as measured during the cold provocation test using the Transonic Laser Doppler Flowmeter
Change in peripheral vasospasm as measured during the cold provocation test as measured using the Transonic Laser Doppler Flowmeter
Change in endothelin-1 levels as measured by an enzyme-linked immunosorbent assay kit
Change in endothelin-1 levels as measured by an enzyme-linked immunosorbent assay kit
Full Information
NCT ID
NCT02376114
First Posted
February 24, 2015
Last Updated
March 2, 2015
Sponsor
Maisonneuve-Rosemont Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02376114
Brief Title
Ginkgo Biloba and Ocular Blood Flow in Primary Open-angle Glaucoma
Official Title
The Effect of Ginkgo Biloba on Ocular Blood Flow in Primary Open-Angle Glaucoma Patients: A Double-Blind Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Glaucoma is one of the leading causes of blindness. Glaucoma progression sometimes occurs despite apparent control of intraocular pressure. Therefore, there may be other factors involved in glaucoma progression in some patients. Evidence is mounting that glaucoma patients are more likely to have abnormal ocular blood flow and vasospasm compared to those without glaucoma. Also, a study showed that those with progressive glaucoma had decreased blood flow compared to those with stable glaucoma or healthy controls. Endothelin-1, a potent vasoconstrictor, may be involved in these blood flow abnormalities. If the dysregulation of blood flow is causally related to the progression of glaucoma, then therapies aimed at improving the regulation of blood flow may help to prevent this progression.
Ginkgo may be part of an effective treatment strategy for glaucoma because it has been shown to improve peripheral and cerebral blood flow. Other properties of Ginkgo that may aid in the treatment of glaucoma include antioxidant properties, inhibition of platelet activating factor, relaxation of smooth muscle, and neuroprotective properties. Ginkgo may be particularly useful in relaxing vasospasm. Two controlled trials have examined the effect of Ginkgo on ocular blood flow in healthy subjects. One randomized crossover trial found that 2 days of Ginkgo increased the end diastolic velocity in the ophthalmic artery compared to placebo. However, another trial found that 1 dose of Ginkgo had no significant effects on ocular blood flow parameters. In people with normal tension glaucoma, Park et al found that 4 weeks of Ginkgo increased peripapillary retinal blood flow. Two randomized controlled trials have examined the impact of Ginkgo biloba on visual field in people with normal tension glaucoma with conflicting results. Clearly, there is a need for more research on this topic.
The goal of our study was to determine whether Ginkgo biloba would result in increased ocular blood flow, reduced vasospasm, and reduced endothelin-1 levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
ocular blood flow, ginkgo biloba, glaucoma, vasospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ginkgo-Placebo
Arm Type
Other
Arm Description
Patients receive Ginkgo biloba and then placebo afterwards.
Arm Title
Placebo-Ginkgo
Arm Type
Other
Arm Description
Patients receive placebo and then Ginkgo biloba afterwards.
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo to Ginkgo biloba
Primary Outcome Measure Information:
Title
Change in optic nerve head blood flow in the rim region as measured with the Heidelberg Retinal Flowmeter
Description
Change in optic nerve head blood flow in the rim region as measured with the Heidelberg Retinal Flowmeter
Time Frame
4 weeks and 10 weeks
Secondary Outcome Measure Information:
Title
Change in retinal blood flow as measured by the Canon Laser Blood Flowmeter
Description
Change in retinal blood flow as measured by the Canon Laser Blood Flowmeter
Time Frame
4 weeks and 10 weeks
Title
Change in ocular pulse amplitude as measured with the Pascal Dynamic Contour Tonometer
Description
Change in ocular pulse amplitude as measured with the Pascal Dynamic Contour Tonometer
Time Frame
4 weeks and 10 weeks
Title
Change in peripheral vasospasm as measured during the cold provocation test using the Transonic Laser Doppler Flowmeter
Description
Change in peripheral vasospasm as measured during the cold provocation test as measured using the Transonic Laser Doppler Flowmeter
Time Frame
4 weeks and 10 weeks
Title
Change in endothelin-1 levels as measured by an enzyme-linked immunosorbent assay kit
Description
Change in endothelin-1 levels as measured by an enzyme-linked immunosorbent assay kit
Time Frame
4 weeks and 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Freeman, PhD
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Lesk, MD
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Ginkgo Biloba and Ocular Blood Flow in Primary Open-angle Glaucoma
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