Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema
Status:
Withdrawn
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
Summary
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.