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

NCT07236645 | Not Yet Recruiting Phase 2

• 1 other identifier: 20250716102337760
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Non-proliferative Diabetic Retinopathy (NPDR)

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• The percentage of glycated hemoglobin (HbA1c)

  2 years

• Urinary Albumin-to-creatinine Ratio （UACR）

  2 years

• Estimated Glomerular Filtration Rate （eGFR）

  2 years

• Motor Nerve Conduction Velocity (MNCV)

  2 years

• Diabetic Retinopathy Severity Scale (DRSS) score

  2 years

Study Arms (2)

Ginaton (ginkgo biloba extract tablet)

EXPERIMENTAL

Drug: Ginaton (ginkgo biloba extract tablet); Other: standard treatment

Control

OTHER

standard treatment

Other: standard treatment

Interventions

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

Ginaton (ginkgo biloba extract tablet)

standard treatment OTHER

standard treatment

Control; Ginaton (ginkgo biloba extract tablet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

ginaton; Ginkgo biloba extract

Central Study Contacts

Kun Liu

CONTACT

+86 18917989522; drliukun@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: November 19, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11