Clinical trial NCT04334564: Effect of Ginkgo Biloba Capsule on Visual Function of Primary Open-angle Glaucoma With Blood Stasis Syndrome
Official title: Effect of Ginkgo Biloba Capsule on Visual Function of Primary Open-angle Glaucoma With Blood Stasis Syndrome: a Randomized, Double-blind, Placebo Parallel Control, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open Angle Glaucoma
Drug Effect
Keywords: Primary Open Angle Glaucoma
Ginkgo biloba capsule
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 512
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Open Angle Glaucoma (POAG) is an eye disease that causes optic nerve damage, visual field defect, and blindness caused by increased intraocular pressure. In recent years, many studies have shown that ginkgo biloba extract has a protective effect on the visual function of glaucoma patients. Studies have shown that Ginkgo biloba capsules can improve the visual field damage of glaucoma controlled by intraocular pressure;Ginkgo biloba capsule can promote the recovery of visual evoked potential of glaucoma controlled by intraocular pressure; the improvement of visual field has a certain correlation with visual electrophysiological recovery. The mechanism may be achieved by suppressing the influx of calcium ions and thereby inhibiting the apoptosis of cells. Therefore, in this clinical study, effect of Ginkgo biloba capsule on visual function of primary open-angle glaucoma with blood stasis syndrome was evaluated by placebo as control.

Detailed description: In this clinical study, the visual field, including MD, MS, LV, and vision score, are the main efficacy indicators. HRT and visual electrophysiological examination are the secondary efficacy indicators. Safety indicators based on laboratory tests and total frequency and incidence of adverse events. To evaluate the effectiveness and safety of Ginkgo biloba capsules for glaucoma patients with intraocular pressure control.

Eligibility criteria: Inclusion Criteria:

* 1. Accord with the diagnostic criteria of primary open-angle glaucoma.
* 2. Accord with the standard of blood stasis and collateralization syndrome in traditional Chinese medicine (TCM).
* 3. Intraocular pressure ≤ 18mmHg
* 4. AGIS score of visual field defect ≥ 6 points and ≤ 17 points, cup to disc ratio \> 0.6, central corrected visual acuity ≥ 0.3.

Exclusion Criteria:

* 1. The diagnoses of angle closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, high intraocular pressure (IOP) and secondary glaucoma.
* 2. Patients with various fundus diseases, such as retinal detachment, retinal vein occlusion, retinal pigmented degeneration, blood or vascular diseases.
* 3. Complicated with cornea, iris, visible lens lesion, or one-eye patient.
* 4. Patients who need to use improved circulation, nutritional nerve drugs during the trial.
* 5. Any eye surgery or laser therapy during the induction period.
* 6. Patients with a history of eye infection during the introduction period.
* 7. Complicated with severe liver and kidney diseases, or abnormal examination of liver and kidney function (ALT,AST ≥ normal upper limit 1.5 times, SCr \> normal upper limit).
* 8. Complicated with severe heart and lung diseases (such as bronchial asthma or history of bronchial asthma, chronic obstructive pulmonary disease, bronchospasm, respiratory failure, etc.), diabetes, advanced tumors, blood and hematopoietic system diseases, or other serious or progressive diseases of the system.
* 9. A person who is prone to bleeding, or who has suffered severe bleeding during the period of introduction.
* 10. Pregnant, lactating women or recent birth plans.
* 11. Other conditions considered inappropriate by the investigator.
* 12. Patients who participated in other clinical trials during the introduction period.

Primary outcomes:
measure: Mean defect of visual field (MD)
timeFrame: After 48 weeks of treatment
Secondary outcomes:
measure: Retinal nerve fiber layer thickness (RNFL)
timeFrame: After 12, 24, 36, and 48 weeks of treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhognshan Ophthalmic Center, Sun Yat-sen University
name: Jian Ge, M.D,Ph.D
role: STUDY_CHAIR
References: