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).
Aged 18 years or older, regardless of gender;
Meeting the diagnostic criteria for diabetes mellitus with glycated hemoglobin (HbA1c) ≤13%;
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);
Voluntarily signing the informed consent form.
Pregnant or lactating women.
Poorly controlled hypertension (defined as ≥180/100 mmHg).
Patients with coexisting ocular pathologies, such as glaucoma or cataract.
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.
Parallel
Ginaton (ginkgo biloba extract tablet)
DrugPatients 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
standard treatment
Other interventionstandard treatment
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.
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.
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.
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.
The percentage of glycated hemoglobin (HbA1c)
Differences in the percentage of glycated hemoglobin (HbA1c) between the two groups over the 2-year treatment period.
Urinary Albumin-to-creatinine Ratio （UACR）
Between-group difference in urinary albumin-to-creatinine ratio (UACR) during the 2-year treatment period.
Estimated Glomerular Filtration Rate （eGFR）
Between-group difference in urinary estimated glomerular filtration rate （eGFR） during the 2-year treatment period.
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.
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