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
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.
The following is a abbreviated list of Inclusion Criteria:
- Definite retinal thickening due to RVO involving the central macula based on
Investigator's clinical evaluation and demonstrated by sdOCT.
- Mean central subfield thickness of at least 300 µm by sdOCT with presence of
- ETDRS BCVA letter score ≤ 76 and ≥ 24.
- Decrease in vision determined to be primarily the result of macular dema due to RVO
and not due to other causes.
The following is a abbreviated list of Exclusion Criteria:
- Macular edema is considered to be due to a cause other than RVO
- Any other ocular disease that may cause substantial reduction in visual acuity,
including iris neovascularization, retinal detachment, epiretinal membrane, vitreous
hemorrhage or fibrosis, ocular inflammation (uveitis), retinal inflammatory,
infectious disease, or primary open-angle glaucoma.
- High myopia (-8 diopter or more correction).
- History of idiopathic or autoimmune uveitis.
- History of any ocular surgery within 3 months prior to Day 1.
- History of panretinal scatter photocoagulation (PRP) or focal laser within 3 months
prior to Day 1.
- History of prior intravitreal, subtenon, or periocular steroid therapy within 3
months prior to Day 1 (e.g., triamcinolone).
- History of prior treatment with intravitreal anti-VEGF treatment within 16 weeks
prior to Day 1.