RecruitingPhase 2NCT06708260

A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME

A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects with Diabetic Macular Edema (DME)


Sponsor

EnnovaBio

Enrollment

60 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ENN0403, high dose and a drug called ENN0403, low dose for people with diabetic macular edema (dme). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGENN0403, low dose

ENN0403 capsules will be orally administered once a day for 12 weeks.

DRUGENN0403, high dose

ENN0403 capsules will be orally administered once a day for 12 weeks.


Locations(1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

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NCT06708260


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