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

Retinal Vein Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387788
• Other study ID #: AKB-9778-CI-4001
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: April 2017

Study information

• Verified date: June 2018
• Source: Aerpio Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

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.

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Aerpio Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity in subjects with RVO	Best corrected visual acuity is measured by ETDRS charts	84 days