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A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME
Sponsor: EnnovaBio
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-12-12
Completion Date
2026-02
Last Updated
2025-02-21
Healthy Volunteers
No
Conditions
Interventions
ENN0403, low dose
ENN0403 capsules will be orally administered once a day for 12 weeks.
ENN0403, 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