This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
151
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
Sham procedure to the study eye at the visits noted per protocol.
Unnamed facility
Gilbert, Arizona, United States
Unnamed facility
Abilene, Texas, United States
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, Week 28
Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Time frame: Baseline, 28 Weeks
Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time frame: Baseline, Week 28
Percentage of Patients with a BCVA of ≥70 Letters
Time frame: 28 Weeks
Percentage of Patients with Resolution of Macular Edema
Time frame: 28 Weeks
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