Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated February 21, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-25; most recent amendment 2025-02-20.
Status change: Not Yet Recruiting → Recruiting 2025-01-09
Trial Details
NCT Number NCT06708260
Lead Sponsor EnnovaBio
Conditions Diabetic Macular Edema (DME)
Enrollment 60 participants
Start Date 2024-12-12
Primary Completion 2025-12 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-02-21