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

Aerpio Therapeutics

Status and phase

Completed

Phase 2

Conditions

Retinal Vein Occlusion

Treatments

Drug: AKB-9778

Study type

Interventional

Funder types

Industry

Identifiers

NCT02387788

AKB-9778-CI-4001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

16 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.