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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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02387788
Study type Interventional
Source Aerpio Therapeutics
Contact
Status Completed
Phase Phase 2
Start date January 2015
Completion date April 2017
View Details
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