Non-proliferative Diabetic Retinopathy (NPDR)Early Phase 1NCT07198815
A Preliminary Exploratory Clinical Trial to Evaluate the Efficacy of NPDR-01 Eye Drops in the Treatment of Non-Proliferative Diabetic Retinopathy
A Early Phase 1 study testing Investigational Eye Drops (NPDR-01) in people with Non-proliferative Diabetic Retinopathy (NPDR) and Diabetic Retinal Microangiopathy, run by Sichuan Academy of Medical Sciences.
Trial summary
This study aims to explore the preliminary clinical efficacy and safety of NPDR-01 eye drops in patients with non-proliferative diabetic retinopathy (NPDR). Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Non-proliferative Diabetic Retinopathy (NPDR), Diabetic Retinal Microangiopathy, Retinal Microaneurysms
- What is being tested?
- Investigational Eye Drops (NPDR-01)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Early Phase 1
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.1. Patients aged 18 to 75 years diagnosed with type 1 or type 2 diabetes mellitus, with non-proliferative diabetic retinopathy (NPDR) confirmed by a qualified ophthalmologist. NPDR diagnosis must be based on current standard fundus examination or retinal photography and should meet the International Clinical Diabetic Retinopathy Disease Severity Scale, with the presence of microaneurysms.
- 1.2. Willing and able to comply with study procedures and provide informed consent: Subjects must voluntarily participate in the study, sign the informed consent form, and fully understand the study objectives, potential drug risks, and research procedures. There should be no other ocular diseases causing retinal neovascularization.
- 1.3. No known significant media opacities that would interfere with fundus image acquisition.
- 1.4. No history of retinal laser photocoagulation, and no anticipated laser treatment within the next 6 months.
- 1.5. No history of intravitreal injection therapies, and no anticipated intravitreal treatments within the next 6 months.
- 1.6. No diabetic macular edema (DME) as defined by central retinal thickness on OCT: <290 μm for females and <305 μm for males (or <305 μm for females and <320 μm for males, depending on the criteria used).
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- 1.7. Clinical fundus examination and ultra-widefield retinal photography show DR changes milder than early proliferative DR (PDR).
- 1.8. No history of ocular surgery. 1.9. Diabetes history: Duration of diabetes ≥ 1 year; glycemic control with HbA1c ≤ 10%.
- 1.10. Visual acuity requirement: Best-corrected visual acuity (BCVA) must be better than 20/400, to ensure reliable assessment of drug efficacy.
Who cannot join
- 2.1. Age Restrictions: Subjects younger than 35 years or older than 75 years. 2.2. Severe Ocular Complications: Subjects whose diabetic retinopathy has progressed to proliferative diabetic retinopathy (PDR) or who present with clinically significant macular edema (CSME). This includes vitreous hemorrhage, retinal detachment, or other acute complications. Also excluded are subjects with severe optic nerve damage or glaucoma (intraocular pressure > 21 mmHg).
- 2.3. Poor Diabetes Control: Subjects with HbA1c > 10%, or with highly fluctuating blood glucose levels that may interfere with efficacy evaluation.
- 2.4. Other Ocular Diseases: Presence of age-related macular degeneration (AMD), retinal vascular occlusion, retinal infections, or other significant ocular pathologies. Also excluded are those with corneal diseases, severe conjunctivitis, or dry eye syndrome that may affect topical ocular drug administration.
- 2.5. History of Ocular Surgery or Treatments: Subjects who received intraocular injections (e.g., anti-VEGF agents) or retinal laser therapy within the past 6 months. Also excluded are those who recently underwent cataract surgery or other retinal-related surgeries.
- 2.6. Other Health Conditions: Subjects with abnormal liver function, disorders in ketone body metabolism, or those with serious systemic diseases that may interfere with treatment (e.g., acute heart disease, liver disease, renal failure). History of cancer or current malignancy, or any major illness affecting drug metabolism or immune function.
- 2.7. Drug Allergy History: Known allergy or hypersensitivity to the study drug or any of its components (e.g., drug carriers, excipients).
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- 2.8. Concomitant Medications: Use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., warfarin, rivaroxaban). Also excluded are those with poorly controlled hypertension, or those who have recently undergone major changes in antihypertensive therapy.
- 2.9. Pregnant or Lactating Women: Pregnant or breastfeeding women are excluded due to potential drug transmission through the placenta or breast milk that could affect the fetus or infant.
- 2.10. Other: Subjects who are unwilling or unable to comply with study procedures or follow-up. Any other individuals deemed unsuitable for the study at the discretion of the investigator.
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
This study aims to explore the preliminary clinical efficacy and safety of NPDR-01 eye drops in patients with non-proliferative diabetic retinopathy (NPDR).
Read the detailed description
The primary objective is to evaluate the drug's potential to reduce microaneurysm formation, improve retinal lesions, and slow disease progression. The secondary objective is to assess the safety profile of NPDR-01, with a focus on the incidence of ocular adverse events.
- Conditions
- Non-proliferative Diabetic Retinopathy (NPDR), Diabetic Retinal Microangiopathy, Retinal Microaneurysms, Diabetic Retinopathy
- Being tested
- Investigational Eye Drops (NPDR-01)
- Keywords
- Diabetic retinopathy, Non-proliferative diabetic retinopathy, Retinal microaneurysms
- Medical subject headings
- Microaneurysm, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Eye Drops (NPDR-01)Drug
NPDR-01 is an investigational ophthalmic solution administered as one drop (50 μL) to the affected eye(s) once daily for a period of 6 months. It is designed to reduce retinal microaneurysms and slow the progression of non-proliferative diabetic retinopathy.
| Study group | Role | What they receive |
|---|---|---|
| NPDR-01 Eye Drops Treatment Group | Experimental | Not described Receives: Drug: Investigational Eye Drops (NPDR-01) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of retinal microaneurysms from baseline to 6 months
To evaluate the clinical efficacy of NPDR-01 eye drops in patients with non-proliferative diabetic retinopathy, specifically in reducing the number of retinal microaneurysms, improving retinopathy status, and delaying disease progression.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment initiation
Secondary outcomes (1)
Incidence of ocular adverse events
Measured: Baseline, 1 month, 3 months, and 6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198815
- Sponsor's protocol ID
- ZLYang
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Exploratory Clinical Trial to Evaluate the Efficacy of NPDR-01 Eye Drops in the Treatment of Non-Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT07198815
- Acronym / sponsor ID
- ZLYang
- Conditions
- Non-proliferative Diabetic Retinopathy (NPDR), Diabetic Retinal Microangiopathy, Retinal Microaneurysms, Diabetic Retinopathy
- Keywords
- Diabetic retinopathy, Non-proliferative diabetic retinopathy, Retinal microaneurysms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Sep 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 aims to explore the preliminary clinical efficacy and safety of NPDR-01 eye drops in patients with non-proliferative diabetic retinopathy (NPDR).
Detailed description
The primary objective is to evaluate the drug's potential to reduce microaneurysm formation, improve retinal lesions, and slow disease progression. The secondary objective is to assess the safety profile of NPDR-01, with a focus on the incidence of ocular adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPDR-01 Eye Drops Treatment Group | Experimental | Drug: Investigational Eye Drops (NPDR-01) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.1. Patients aged 18 to 75 years diagnosed with type 1 or type 2 diabetes mellitus, with non-proliferative diabetic retinopathy (NPDR) confirmed by a qualified ophthalmologist. NPDR diagnosis must be based on current standard fundus examination or retinal photography and should meet the International Clinical Diabetic Retinopathy Disease Severity Scale, with the presence of microaneurysms.
- 1.2. Willing and able to comply with study procedures and provide informed consent: Subjects must voluntarily participate in the study, sign the informed consent form, and fully understand the study objectives, potential drug risks, and research procedures. There should be no other ocular diseases causing retinal neovascularization.
- 1.3. No known significant media opacities that would interfere with fundus image acquisition.
- 1.4. No history of retinal laser photocoagulation, and no anticipated laser treatment within the next 6 months.
- 1.5. No history of intravitreal injection therapies, and no anticipated intravitreal treatments within the next 6 months.
Key exclusion criteria (9 listed)
- 2.1. Age Restrictions: Subjects younger than 35 years or older than 75 years. 2.2. Severe Ocular Complications: Subjects whose diabetic retinopathy has progressed to proliferative diabetic retinopathy (PDR) or who present with clinically significant macular edema (CSME). This includes vitreous hemorrhage, retinal detachment, or other acute complications. Also excluded are subjects with severe optic nerve damage or glaucoma (intraocular pressure > 21 mmHg).
- 2.3. Poor Diabetes Control: Subjects with HbA1c > 10%, or with highly fluctuating blood glucose levels that may interfere with efficacy evaluation.
- 2.4. Other Ocular Diseases: Presence of age-related macular degeneration (AMD), retinal vascular occlusion, retinal infections, or other significant ocular pathologies. Also excluded are those with corneal diseases, severe conjunctivitis, or dry eye syndrome that may affect topical ocular drug administration.
- 2.5. History of Ocular Surgery or Treatments: Subjects who received intraocular injections (e.g., anti-VEGF agents) or retinal laser therapy within the past 6 months. Also excluded are those who recently underwent cataract surgery or other retinal-related surgeries.
- 2.6. Other Health Conditions: Subjects with abnormal liver function, disorders in ketone body metabolism, or those with serious systemic diseases that may interfere with treatment (e.g., acute heart disease, liver disease, renal failure). History of cancer or current malignancy, or any major illness affecting drug metabolism or immune function.
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 |
|---|---|---|
| Investigational Eye Drops (NPDR-01)NPDR-01 is an investigational ophthalmic solution administered as one drop (50 μL) to the affected eye(s) once daily for a period of 6 months. It is designed to reduce retinal microaneurysms and slow the progression of non-proliferative diabetic retinopathy. | Drug | NPDR-01 Eye Drops Treatment Group |
Primary outcome
Change in the number of retinal microaneurysms from baseline to 6 months
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment initiation
To evaluate the clinical efficacy of NPDR-01 eye drops in patients with non-proliferative diabetic retinopathy, specifically in reducing the number of retinal microaneurysms, improving retinopathy status, and delaying disease progression.
1 secondary outcome
Incidence of ocular adverse events
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment initiation
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 30 Sep 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 Early Phase 1 study testing Investigational Eye Drops (NPDR-01) in people with Non-proliferative Diabetic Retinopathy (NPDR) and Diabetic Retinal Microangiopathy, run by Sichuan Academy of Medical Sciences.
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 9 inclusion and 9 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 30 Sep 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jie Ma ((+86)18080949902, majie92v@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of retinal microaneurysms from baseline to 6 months (time frame: Baseline, 1 month, 3 months, and 6 months after treatment initiation). 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 30 Sep 2025.