This is an open label dose-escalation study to evaluate the safety and treatment benefits of MS-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. Fifteen subjects with diabetic macular edema will be enrolled into each of three dose cohorts and will receive oral administration of MS-553 for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
MS-553
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGShanghai General Hospital
Shanghai, China
RECRUITINGTreatment-emergent adverse events
Time frame: Baseline to Day 56
Mean change in the central retina subfield thickness (CRT)
Time frame: Baseline to Day 56
Mean change in the retinal volume
Time frame: Baseline to Day 56
Proportion of patients with >20% reduction in CRT
Time frame: Baseline to Day 56
Proportion of patients with resolution of central involved macular edema
Time frame: Baseline to Day 56
Average mean change in best corrected visual acuity
Time frame: Baseline to Day 56
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