The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with diabetic macular edema (DME). This study will evaluate the percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
Site US10021
Phoenix, Arizona, United States
Site US10025
Tucson, Arizona, United States
Percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence tomography (SD-OCT) at Month 3
Time frame: Baseline and Month 3
Absolute change from baseline in CST in the study eye as assessed by SD-OCT at Month 3
Time frame: Baseline and Month 3
Change from baseline in early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) score in the study eye at Month 3
Time frame: Baseline and Month 3
Absolute and percent change from baseline in excess CST in the study eye as assessed by SD-OCT at Months 1 and 2
Time frame: Baseline and Months 1, 2
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intravitreal (IVT) injection
Site US10006
Arcadia, California, United States
Site US10004
Beverly Hills, California, United States
Site US10007
Palm Desert, California, United States
Site US10011
Sacramento, California, United States
Site US10031
Santa Ana, California, United States
Site US10029
Golden, Colorado, United States
Site US10016
Miami, Florida, United States
Site US10005
Winter Haven, Florida, United States
...and 11 more locations