Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
Completed · Phase 1/Phase 2
Conditions studied: Macular Edema, Retinal Vein Occlusion
In brief
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.
Key facts
- Study ID
- NCT01027650
- Run by
- Allergan
- People needed
- 121
- Starts
- 2010-03-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2014-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- macular edema due to retinal vein occlusion
- visual acuity in the study eye between 20/320 to 20/40
You may not qualify if…
- cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)
- use of injectable drugs in the study eye within 2 months prior to day 1
- active eye infection in either eye
- visual acuity in the non-study eye of 20/200 or worse
Where it is running
- Study site — Phoenix, Arizona, United States
- Study site — East Melbourne, Victoria, Australia
- Study site — London, Ontario, Canada
- Study site — Tel Aviv, Israel
- Study site — Cape Town, South Africa
Full record on ClinicalTrials.gov
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