Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy: A Single-Center, Open-Label, Parallel-Group Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Retinal Vessel Density
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ginaton (ginkgo biloba extract tablet)
干预措施: Ginaton (ginkgo biloba extract tablet) (Drug)
Ginaton (ginkgo biloba extract tablet)
干预措施: standard treatment (Other)
Control
standard treatment
干预措施: standard treatment (Other)
结局指标
主要结局
Retinal Vessel Density
时间窗: 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.
Vessel Length Density
时间窗: 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.
Vascular Index
时间窗: 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.
Perfusion Area
时间窗: 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.
Choroidal Vessel Volume
时间窗: 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.
Foveal Avascular Zone Area
时间窗: 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.
Stromal Volume
时间窗: 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.
Stromal Index
时间窗: 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.
次要结局
- 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)
- 36-item Short-Form (SF-36) score over the 2-year treatment period(2 years)
- Whole Blood Viscosity(2 years)
- Plasma Viscosity(2 years)
- Hematocrit(2 years)
- Fibrinogen(2 years)
- Sensory Nerve Conduction Velocity (SNCV)(2 years)
研究者
Kun Liu
Chief Physician, Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine