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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02387788
First Posted: March 13, 2015
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aerpio Therapeutics
  Purpose
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.

Condition Intervention Phase
Retinal Vein Occlusion Drug: AKB-9778 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Aerpio Therapeutics:

Primary Outcome Measures:
  • Visual acuity in subjects with RVO [ Time Frame: 84 days ]
    Best corrected visual acuity is measured by ETDRS charts


Enrollment: 16
Actual Study Start Date: January 2015
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387788


Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Aerpio Therapeutics
Investigators
Principal Investigator: Peter A Campochiaro, MD Wilmer Eye Institute
  More Information

Responsible Party: Aerpio Therapeutics
ClinicalTrials.gov Identifier: NCT02387788     History of Changes
Other Study ID Numbers: AKB-9778-CI-4001
First Submitted: March 5, 2015
First Posted: March 13, 2015
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases