Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778 administered twice daily for 84 days in subjects with macular edema due to RVO.
Subjects will participate in the study for up to 168 days. Up to 20 subjects will be enrolled in the study. Subjects will self-administer study medication as subcutaneous (SC) injections in the abdomen (preferably) twice per day; the first dose each day should be administered in the morning and the evening dose should be administered within 8 to 16 hours after the morning dose. Safety assessments will be conducted at each study visit during treatment and AEs will be collected throughout the Treatment period and during the 56-days observation period visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778 administered twice daily for 84 days in subjects with macular edema due to RVO.
Wilmer Eye Institute
Baltimore, Maryland, United States
Visual acuity in subjects with RVO
Best corrected visual acuity is measured by ETDRS charts
Time frame: 84 days
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