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

ConditionsNon-proliferative Diabetic Retinopathy (NPDR)Diabetic Retinal MicroangiopathyRetinal MicroaneurysmsDiabetic Retinopathy
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age35-75
SponsorSichuan Academy of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: NPDR-01 Eye Drops Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 1 month, 3 months, and 6 months after treatment initiation

Secondary outcomes

1

Incidence of ocular adverse events

Time frame
Baseline, 1 month, 3 months, and 6 months after treatment initiation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: