The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of up to 3 dose levels of EBI-031 given as an intravitreal injection in subjects with diabetic macular edema. There are two arms to the study, a single dose arm (1 dose) and a repeat dose arm (1 dose each month for 3 months). Eligible subjects will initially enroll in the single dose arm and 3 to 6 subjects will be dosed at each of the 3 dose levels. Safety will be assessed over the 28 days after the single dose prior to moving to the next higher dose level. Once all subjects in the single dose arm have been dosed with EBI-031 and the safety has been assessed eligible subjects will begin enrolling in the repeat dose arm. Subjects in the repeat dose arm will receive one dose each month for 3 months and will be assessed for safety. Escalation to the next higher dose will occur once it is determined safe to proceed to the next dose level. Six subjects will be dosed at each of the 3 dose levels.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Safety, tolerability, and immunogenicity as measured by adverse events and anti-drug antibody development of single and repeat doses of EBI-031
Number of Participants With Abnormal Laboratory Values, Adverse Events, and/or antibodies to EBI-031
Time frame: Measure over the 84 days
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