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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
2026-08-20
Last Updated
2026-10-05
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 (9)
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Hebei Eye Hospital
Xingtai, Hebei, China
Zhengzhou Second Hospital
Zhengzhou, Henan, China
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, China
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Xian No.1 Hospital
Xi’an, Shanxi, China
Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China