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OpenTrials
Completed

NCT Number: NCT02387788

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 macular edema due to RVO.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AKB-9778

Drug

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 outcomes

  1. Visual acuity in subjects with RVO

    Time frame: 84 days

    Best corrected visual acuity is measured by ETDRS charts

Sponsors and collaborators

Lead sponsor

Aerpio Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2015
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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