NCT00543296

Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.

Detailed description

Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant. Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	0.59 mg Fluocinolone Acetonide implant	0.59 mg Fluocinolone Acetonide implant

Timeline

• Start date: 2004-03-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2007-10-12
• Last updated: 2015-03-31
• Results posted: 2014-07-09

Locations

1 site across 1 country: United States