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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат 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
• Другое standard treatment
  standard treatment

Первичные конечные точки

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

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07236645 · 20250716102337760

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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