Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
| Status: | Archived |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2010 |
| End Date: | January 2013 |
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.
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