NCT01027650

Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.

Conditions

• Macular Edema
• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	AGN208397 intravitreal injection	AGN208397 intravitreal injection on Day 1.
DRUG	dexamethasone intravitreal implant	Dexamethasone 700 ug intravitreal implant on Day 1.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-04-01
• Completion: 2013-02-01
• First posted: 2009-12-08
• Last updated: 2014-04-29
• Results posted: 2014-04-29

Locations

5 sites across 5 countries: United States, Australia, Canada, Israel, South Africa