Trials / Not Yet Recruiting
Not Yet RecruitingNCT07198815
A Preliminary Exploratory Clinical Trial to Evaluate the Efficacy of NPDR-01 Eye Drops in the Treatment of Non-Proliferative Diabetic Retinopathy
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Sichuan Academy of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2025-09-30
- Last updated
- 2025-09-30
Source: ClinicalTrials.gov record NCT07198815. Inclusion in this directory is not an endorsement.