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

Phase 4

Completed

• Conditions: Uveitis
• Interventions: Drug: 0.59 mg Fluocinolone Acetonide implant

• Registration Number: NCT00543296
• Lead Sponsor: Duke University

Brief 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

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-12
• Results First Submitted: 2013-08-08
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-09
• Results First Posted: 2014-07-09
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Non-infectious intermediate, posterior or panuveitis
• Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug

Exclusion Criteria

• Infectious uveitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.59 mg Fluocinolone Acetonide implant	0.59 mg Fluocinolone Acetonide implant	0.59 mg Fluocinolone Acetonide implant

Primary Outcome Measures

Name	Time	Method
Number of Eyes With Inflammation Recurrence	5 years	Number of eyes with inflammation recurrence

Secondary Outcome Measures

Name	Time	Method
Percentage of Eyes With Improvement in Visual Acuity	baseline to 52 weeks	Visual acuity was improved by two or more lines from baseline.
Number of Participant's Eye Requiring Adjunctive Therapy	5 years	Adjunctive Therapy needed to control inflammation in the implanted eye
Number of Eyes With Increased Intraocular Pressure	52 weeks

Trial Locations

Locations (1)

Duke University Eye Center; 🇺🇸 Durham, North Carolina, United States