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

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 Retinal Vein Occlusion

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.

Study Overview

• Status: Completed
• Conditions: Retinal Vein Occlusion
• Intervention / Treatment: Drug: AKB-9778

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Wilmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15 mg AKB-9778 BID for 84 days; Subcutaneous AKB-9778 15 mg BID (total dose of 30 mg/day) for 84 days	Drug: AKB-9778; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity in subjects with RVO	Best corrected visual acuity is measured by ETDRS charts	84 days

Collaborators and Investigators

• Sponsor: Aerpio Therapeutics
• Investigators: Principal Investigator: Peter A Campochiaro, MD, Wilmer Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 5, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion
• Other Study ID Numbers: AKB-9778-CI-4001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO