At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
In Brief
A Phase 2 clinical trial evaluating AGN208397 intravitreal injection and dexamethasone intravitreal implant for Macular Edema and Retinal Vein Occlusion. Completed, enrolled 121 participants across 5 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
AGN208397 intravitreal injection on Day 1.
Dexamethasone 700 ug intravitreal implant on Day 1.