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NCT Number: NCT07236645

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

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).

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Key information

Conditions

Non-proliferative Diabetic Retinopathy (NPDR)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ginaton (ginkgo biloba extract tablet)

Drug

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

standard treatment

Other

standard treatment

Primary outcomes

  1. Retinal Vessel Density

    Time frame: 2 years

    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. Vessel Length Density

    Time frame: 2 years

    The difference between groups in the change of vessel length density from baseline within 2 years of treatment (at month 24), assessed by OCTA.

  3. Vascular Index

    Time frame: 2 years

    The difference between groups in the change of vascular index from baseline within 2 years of treatment (at month 24), assessed by OCTA.

  4. Perfusion Area

    Time frame: 2 years

    The difference between groups in the change of perfusion area from baseline within 2 years of treatment (at month 24), assessed by OCTA.

  5. Choroidal Vessel Volume

    Time frame: 2 years

    The difference between groups in the change of choroidal vessel volume from baseline within 2 years of treatment (at month 24), assessed by OCTA.

  6. Foveal Avascular Zone Area

    Time frame: 2 years

    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.

  7. Stromal Volume

    Time frame: 2 years

    The difference between groups in the change of stromal volume from baseline within 2 years of treatment (at month 24), assessed by OCTA.

  8. Stromal Index

    Time frame: 2 years

    The difference between groups in the change of stromal index from baseline within 2 years of treatment (at month 24), assessed by OCTA.

Secondary outcomes

  1. The percentage of glycated hemoglobin (HbA1c)

    Time frame: 2 years

    Differences in the percentage of glycated hemoglobin (HbA1c) between the two groups over the 2-year treatment period.

  2. Urinary Albumin-to-creatinine Ratio （UACR）

    Time frame: 2 years

    Between-group difference in urinary albumin-to-creatinine ratio (UACR) during the 2-year treatment period.

  3. Estimated Glomerular Filtration Rate （eGFR）

    Time frame: 2 years

    Between-group difference in urinary estimated glomerular filtration rate （eGFR） during the 2-year treatment period.

  4. Motor Nerve Conduction Velocity (MNCV)

    Time frame: 2 years

    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.

  5. Diabetic Retinopathy Severity Scale (DRSS) score

    Time frame: 2 years

    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)

  6. 36-item Short-Form (SF-36) score over the 2-year treatment period

    Time frame: 2 years

    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.

  7. Whole Blood Viscosity

    Time frame: 2 years

    The between-group difference in whole blood viscosity (a hemorheological parameter) during the 2-year treatment period.

  8. Plasma Viscosity

    Time frame: 2 years

    The between-group difference in plasma viscosity (a hemorheological parameter) during the 2-year treatment period.

  9. Hematocrit

    Time frame: 2 years

    The between-group difference in hematocrit (a hemorheological parameter) during the 2-year treatment period.

  10. Fibrinogen

    Time frame: 2 years

    The between-group difference in fibrinogen (a hemorheological parameter) during the 2-year treatment period.

  11. Sensory Nerve Conduction Velocity (SNCV)

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kun Liu

CONTACT

[email protected]

+86 18917989522

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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