Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy

Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy: A Single-Center, Open-Label, Parallel-Group Controlled Trial

This study is a single-center, open-label, parallel-controlled trial, scheduled to commence in October 2025 at the outpatient and inpatient departments of Shanghai General Hospital. Eligible patients with diabetes mellitus and/or non-proliferative diabetic retinopathy (NPDR), who meet the inclusion and exclusion criteria, will be recruited. General and disease-related information will be collected. All eligible participants will be required to voluntarily sign an informed consent form after fully understanding and accepting the study. Successfully enrolled subjects will be randomly assigned to the Ginaton group or the conventional treatment group, and will receive the corresponding interventions as specified in the study protocol. Follow-up assessments will include blood pressure, blood glucose, glycated hemoglobin, blood lipids, hemorheological parameters, glomerular filtration rate, microalbuminuria, nerve conduction velocity by electromyography, visual acuity, wide-field fundus photography, quality of life (SF-36 questionnaire), and adverse events. The study aims to evaluate the efficacy and safety of ginkgo biloba extract tablet in preventing the development of diabetic retinopathy in patients with long-standing diabetes, as well as in treating patients with mild to moderate NPDR without concomitant diabetic macular edema (DME).

Study Overview

• Status: Not yet recruiting
• Conditions: Non-proliferative Diabetic Retinopathy (NPDR)
• Intervention / Treatment: Other: standard treatment; Drug: Ginaton (ginkgo biloba extract tablet)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kun Liu; Phone Number: +86 18917989522; Email: drliukun@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 years or older, regardless of gender;
2. Meeting the diagnostic criteria for diabetes mellitus with glycated hemoglobin (HbA1c) ≤13%;
3. Having a diabetes duration ≥5 years without diagnosed diabetic retinopathy or, according to the DR staging criteria proposed by the Group of Fundus Diseases, Ophthalmology Society of Chinese Medical Association in 2014, having at least one eye diagnosed with Stage I or II non-proliferative diabetic retinopathy (NPDR) without concomitant diabetic macular edema (DME);
4. Voluntarily signing the informed consent form.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Poorly controlled hypertension (defined as ≥180/100 mmHg).
3. Patients with coexisting ocular pathologies, such as glaucoma or cataract.
4. Patients with severe impairment of cardiac, pulmonary, hepatic, or renal function, or coagulation disorders, e.g., alanine aminotransferase (ALT) ≥2 times the upper limit of normal (ULN), aspartate aminotransferase (AST) ≥2 ULN, total bilirubin (BIL) ≥1.5 ULN, or estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m².
5. Patients with comorbid psychiatric or neurological disorders.
6. Patients with a known allergy to any component of the investigational product.
7. Patients who received Ginkgo biloba extract treatment within the past 12 months.
8. Patients with a history of intraocular treatments, such as panretinal photocoagulation (PRP), and/or anti-vascular endothelial growth factor (VEGF) therapy, and/or ocular surgery.
9. Patients with a history of cardiovascular events or conditions requiring long-term anticoagulation therapy, such as deep vein thrombosis, pulmonary embolism, atrial fibrillation, or cardiac valve replacement.
10. Any contraindication that, in the investigator's judgment, could limit clinical assessment or treatment.
11. Concurrent participation in any other clinical trial.
12. Patients deemed by the investigator to be unsuitable for inclusion in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; standard treatment	Other: standard treatment; standard treatment
Experimental: Ginaton (ginkgo biloba extract tablet)	Other: standard treatment; standard treatment; Drug: Ginaton (ginkgo biloba extract tablet); Patients in the Ginaton arm, in addition to receiving standard treatment, were administered Ginaton orally at a dose of two tablets (40 mg/tablet) three times daily (after morning, noon, and evening meals) for 2 years, starting from enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal Vessel Density	The difference between groups in the change of retinal vessel density from baseline within 2 years of treatment (at month 24), assessed by OCTA.	2 years
Vessel Length Density	The difference between groups in the change of vessel length density from baseline within 2 years of treatment (at month 24), assessed by OCTA.	2 years
Vascular Index	The difference between groups in the change of vascular index from baseline within 2 years of treatment (at month 24), assessed by OCTA.	2 years
Perfusion Area	The difference between groups in the change of perfusion area from baseline within 2 years of treatment (at month 24), assessed by OCTA.	2 years
Choroidal Vessel Volume	The difference between groups in the change of choroidal vessel volume from baseline within 2 years of treatment (at month 24), assessed by OCTA.	2 years
Foveal Avascular Zone Area	The difference between groups in the change of foveal avascular zone area from baseline within 2 years of treatment (at month 24), assessed by OCTA.	2 years
Stromal Volume	The difference between groups in the change of stromal volume from baseline within 2 years of treatment (at month 24), assessed by OCTA.	2 years
Stromal Index	The difference between groups in the change of stromal index from baseline within 2 years of treatment (at month 24), assessed by OCTA.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of glycated hemoglobin (HbA1c)	Differences in the percentage of glycated hemoglobin (HbA1c) between the two groups over the 2-year treatment period.	2 years
Urinary Albumin-to-creatinine Ratio （UACR）	Between-group difference in urinary albumin-to-creatinine ratio (UACR) during the 2-year treatment period.	2 years
Estimated Glomerular Filtration Rate （eGFR）	Between-group difference in urinary estimated glomerular filtration rate （eGFR） during the 2-year treatment period.	2 years
Motor Nerve Conduction Velocity (MNCV)	Differences in motor nerve conduction velocity (MNCV) of the median and common peroneal nerves from baseline at each visit over the 2-year treatment period.	2 years
Diabetic Retinopathy Severity Scale (DRSS) score	Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)	2 years
36-item Short-Form (SF-36) score over the 2-year treatment period	Differences in quality of life scores based on the 36-Item Short Form Health Survey between the two groups over the 2-year treatment period.The score for each of the eight health domains and the two summary measures ranges from 0 to 100.A higher score indicates a more favorable health state.	2 years
Whole Blood Viscosity	The between-group difference in whole blood viscosity (a hemorheological parameter) during the 2-year treatment period.	2 years
Plasma Viscosity	The between-group difference in plasma viscosity (a hemorheological parameter) during the 2-year treatment period.	2 years
Hematocrit	The between-group difference in hematocrit (a hemorheological parameter) during the 2-year treatment period.	2 years
Fibrinogen	The between-group difference in fibrinogen (a hemorheological parameter) during the 2-year treatment period.	2 years
Sensory Nerve Conduction Velocity (SNCV)	Differences in sensory nerve conduction velocity (SNCV) of the median and superficial peroneal nerves from baseline at each visit over the 2-year treatment period.	2 years

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 8, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: ginaton; Ginkgo biloba extract
• Other Study ID Numbers: 20250716102337760

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No