The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with diabetic macular edema (DME).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Winter Haven, Florida, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Incidence and severity of adverse events (AEs).
Time frame: 28 days
Change from baseline in physical exams.
Time frame: 28 days
Change from baseline in vital signs.
Time frame: 28 days
Change from baseline in electrocardiograms (ECGs).
Time frame: 28 days
Change from baseline in opthalmic exams.
Time frame: 28 days
Change from baseline in clinical laboratory assay results.
Blood chemistry, hematology and urinalysis.
Time frame: 28 days
Pharmacokinetics of AKB-9778
Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).
Time frame: Day 1 and Day 14
Change from baseline in optical tomography (OCT)-measured retinal thickness.
Time frame: 28 days
Change from baseline in best corrected visual acuity (BCVA).
Time frame: 28 days
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Unnamed facility
Charlotte, North Carolina, United States
Unnamed facility
Cincinnati, Ohio, United States