Phase 2Completed
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 (Industry)
- Enrolment
- 60 enrolled
- Conditions
- Diabetic Macular Edema (DME)
- Interventions
- ENN0403, low dose; ENN0403, high dose
- Ages
- adults, older adults
- Registry
- NCT06708260
From the registry
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.
Primary outcomes
- Change from baseline in Central Retinal Thickness (CRT) at week 12