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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg AKB-9778 BID for 84 days | Experimental | Subcutaneous AKB-9778 15 mg BID (total dose of 30 mg/day) for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity in subjects with RVO | Best corrected visual acuity is measured by ETDRS charts | 84 days |
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The following is a abbreviated list of Inclusion Criteria:
The following is a abbreviated list of Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A Campochiaro, MD | Wilmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| C000598564 | AKB-9778 |
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| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |