NCT00661479

An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DRUG	400 µg Brimonidine Tartrate Implant	400 µg brimonidine tartrate implant in the study eye on Day 1.
DRUG	200 µg Brimonidine Tartrate Implant	200 µg brimonidine tartrate implant in the study eye on Day 1.
DRUG	100 µg Brimonidine Tartrate Implant	100 µg brimonidine tartrate implant in the study eye on Day 1.
OTHER	Sham (no implant)	Sham in the fellow eye on Day 1.

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-12-01
• Completion: 2010-05-01
• First posted: 2008-04-18
• Last updated: 2013-04-24
• Results posted: 2013-04-24

Locations

4 sites across 4 countries: United States, France, Germany, Portugal