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

Official title

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

Overview

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).

Interventions

• 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
• Other standard treatment
  standard treatment

Primary outcome measures

• Retinal Vessel Density [Time frame: 2 years]
• Vessel Length Density [Time frame: 2 years]
• Vascular Index [Time frame: 2 years]
• Perfusion Area [Time frame: 2 years]
• Choroidal Vessel Volume [Time frame: 2 years]
• Foveal Avascular Zone Area [Time frame: 2 years]
• Stromal Volume [Time frame: 2 years]
• Stromal Index [Time frame: 2 years]

Secondary outcome measures (11)

• The percentage of glycated hemoglobin (HbA1c) [Time frame: 2 years]
• Urinary Albumin-to-creatinine Ratio （UACR） [Time frame: 2 years]
• Estimated Glomerular Filtration Rate （eGFR） [Time frame: 2 years]
• Motor Nerve Conduction Velocity (MNCV) [Time frame: 2 years]
• Diabetic Retinopathy Severity Scale (DRSS) score [Time frame: 2 years]
• 36-item Short-Form (SF-36) score over the 2-year treatment period [Time frame: 2 years]
• Whole Blood Viscosity [Time frame: 2 years]
• Plasma Viscosity [Time frame: 2 years]
• Hematocrit [Time frame: 2 years]
• Fibrinogen [Time frame: 2 years]
• Sensory Nerve Conduction Velocity (SNCV) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Patients with comorbid psychiatric or neurological disorders.
• Patients with a known allergy to any component of the investigational product.
• Patients who received Ginkgo biloba extract treatment within the past 12 months.
• 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.
• 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.
• Any contraindication that, in the investigator's judgment, could limit clinical assessment or treatment.
• Concurrent participation in any other clinical trial.
• Patients deemed by the investigator to be unsuitable for inclusion in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07236645 · 20250716102337760

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗