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
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedJune 27, 2018
June 1, 2018
2.2 years
March 5, 2015
June 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity in subjects with RVO
Best corrected visual acuity is measured by ETDRS charts
84 days
Study Arms (1)
15 mg AKB-9778 BID for 84 days
EXPERIMENTALSubcutaneous AKB-9778 15 mg BID (total dose of 30 mg/day) for 84 days
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A Campochiaro, MD
Wilmer Eye Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 13, 2015
Study Start
January 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
June 27, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share