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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
ENN0403 capsules will be orally administered once a day for 12 weeks.
ENN0403 capsules will be orally administered once a day for 12 weeks.
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGChange from baseline in Central Retinal Thickness (CRT) at week 12
Time frame: week 12
Change from baseline in Best Corrected Visual Acuity (BCVA) at week 4, 8, and 12
Time frame: week 4, 8, 12
Change from baseline in CRT at week 4 and 8
Time frame: week 4, 8
Incidence of ocular and non-ocular TEAE and SAE
Time frame: 12 weeks
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