Back to resultsOpen Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO
Primary Purpose
Retinal Vein Occlusion
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AKB-9778
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Vein Occlusion
Eligibility 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.
Sites / Locations
- Wilmer Eye Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
15 mg AKB-9778 BID for 84 days
Arm Description
Subcutaneous AKB-9778 15 mg BID (total dose of 30 mg/day) for 84 days
Outcomes
Primary Outcome Measures
Visual acuity in subjects with RVO
Best corrected visual acuity is measured by ETDRS charts
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02387788
Brief Title
Open Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerpio Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
15 mg AKB-9778 BID for 84 days
Arm Type
Experimental
Arm Description
Subcutaneous AKB-9778 15 mg BID (total dose of 30 mg/day) for 84 days
Intervention Type
Drug
Intervention Name(s)
AKB-9778
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual acuity in subjects with RVO
Description
Best corrected visual acuity is measured by ETDRS charts
Time Frame
84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Campochiaro, MD
Organizational Affiliation
Wilmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO
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