Open Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerpio Therapeutics

Criteria

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 intraretinal fluid

• 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.