Open Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO
|ClinicalTrials.gov Identifier: NCT02387788|
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Retinal Vein Occlusion||Drug: AKB-9778||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Experimental: 15 mg AKB-9778 BID for 84 days
Subcutaneous AKB-9778 15 mg BID (total dose of 30 mg/day) for 84 days
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.
- Visual acuity in subjects with RVO [ Time Frame: 84 days ]Best corrected visual acuity is measured by ETDRS charts
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387788
|United States, Maryland|
|Wilmer Eye Institute|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Peter A Campochiaro, MD||Wilmer Eye Institute|