A Preliminary Exploratory Clinical Trial to Evaluate the Efficacy of NPDR-01 Eye Drops in the Treatment of Non-Proliferative Diabetic Retinopathy

Sponsor
Sichuan Academy of Medical Sciences
Study ID
NCT07198815
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Diabetic Retinal Microangiopathy
  • Diabetic Retinopathy
  • Non-proliferative Diabetic Retinopathy (NPDR)
  • Retinal Microaneurysms

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

This study aims to explore the preliminary clinical efficacy and safety of NPDR-01 eye drops in patients with non-proliferative diabetic retinopathy (NPDR).

Key Dates

First listed
Sep 30, 2025
Start date
Dec 1, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NPDR-01 Eye Drops Treatment Group

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 ]

Central Contacts

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