NCT01702441

Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema

Phase 1b/2a Open Label, Multiple-Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pilot Efficacy, Pharmacokinetics and Pharmacodynamic Effects of 28 Day Repeat Subcutaneous Doses of AKB-9778 in Subjects With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Aerpio Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with diabetic macular edema (DME).

Conditions

• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
DRUG	Subcutaneous AKB-9778

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-09-01
• Completion: 2014-12-01
• First posted: 2012-10-08
• Last updated: 2015-03-27

Locations

6 sites across 1 country: United States