Non-proliferative Diabetic Retinopathy (NPDR)Phase 2NCT07236645
Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy
A Phase 2 study testing Ginaton (ginkgo biloba extract tablet) and standard treatment in people with Non-proliferative Diabetic Retinopathy (NPDR), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-proliferative Diabetic Retinopathy (NPDR)
- What is being tested?
- Ginaton (ginkgo biloba extract tablet) and standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy: A Single-Center, Open-Label, Parallel-Group Controlled Trial
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).
- Being tested
- Ginaton (ginkgo biloba extract tablet), standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 treatmentOther
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Ginaton (ginkgo biloba extract tablet) | Experimental | Not described Receives: Drug: Ginaton (ginkgo biloba extract tablet); Other: standard treatment |
| Control | Other | standard treatment Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Secondary outcomes (11)
The percentage of glycated hemoglobin (HbA1c)
Differences in the percentage of glycated hemoglobin (HbA1c) between the two groups over the 2-year treatment period.
Measured: 2 years
Urinary Albumin-to-creatinine Ratio （UACR）
Between-group difference in urinary albumin-to-creatinine ratio (UACR) during the 2-year treatment period.
Measured: 2 years
Estimated Glomerular Filtration Rate （eGFR）
Between-group difference in urinary estimated glomerular filtration rate （eGFR） during the 2-year treatment period.
Measured: 2 years
Motor Nerve Conduction Velocity (MNCV)
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.
Measured: 2 years
Diabetic Retinopathy Severity Scale (DRSS) score
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)
Measured: 2 years
36-item Short-Form (SF-36) score over the 2-year treatment period
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.
Measured: 2 years
Whole Blood Viscosity
The between-group difference in whole blood viscosity (a hemorheological parameter) during the 2-year treatment period.
Measured: 2 years
Plasma Viscosity
The between-group difference in plasma viscosity (a hemorheological parameter) during the 2-year treatment period.
Measured: 2 years
Hematocrit
The between-group difference in hematocrit (a hemorheological parameter) during the 2-year treatment period.
Measured: 2 years
Fibrinogen
The between-group difference in fibrinogen (a hemorheological parameter) during the 2-year treatment period.
Measured: 2 years
Sensory Nerve Conduction Velocity (SNCV)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-proliferative Diabetic Retinopathy (NPDR)Studies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Liu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236645
- Sponsor's protocol ID
- 20250716102337760
- Status last verified
- Nov 2025
- First submitted
- 8 Oct 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy: A Single-Center, Open-Label, Parallel-Group Controlled Trial
- ClinicalTrials.gov ID
- NCT07236645
- Acronym / sponsor ID
- 20250716102337760
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginaton (ginkgo biloba extract tablet) | Experimental | Drug: Ginaton (ginkgo biloba extract tablet), Other: standard treatment |
| Control | Other | Other: standard treatmentstandard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Ginaton (ginkgo biloba extract tablet) |
| standard treatmentstandard treatment | Other | Control, Ginaton (ginkgo biloba extract tablet) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginaton (ginkgo biloba extract tablet) and standard treatment in people with Non-proliferative Diabetic Retinopathy (NPDR), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun Liu (+86 18917989522, drliukun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Vessel Density (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.