NCT00972374

Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.

Conditions

• Rhegmatogenous Macula-off Retinal Detachment

Interventions

Type	Name	Description
DRUG	400 ug Brimonidine Implant	400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
DRUG	200 ug Brimonidine Implant	200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
OTHER	Sham (no implant)	Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-10-01
• Completion: 2011-07-01
• First posted: 2009-09-04
• Last updated: 2013-04-24
• Results posted: 2013-04-24

Locations

6 sites across 6 countries: United States, India, Israel, Philippines, South Korea, United Kingdom