Open Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO
|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.|
|ClinicalTrials.gov Identifier: NCT02387788|
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : June 27, 2018
|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
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
|United States, Maryland|
|Wilmer Eye Institute|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Peter A Campochiaro, MD||Wilmer Eye Institute|