Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Overview
- Phase
- Phase 4
- Intervention
- 0.59 mg Fluocinolone Acetonide implant
- Conditions
- Uveitis
- Sponsor
- Duke University
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Number of Eyes With Inflammation Recurrence
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
0.59 mg Fluocinolone Acetonide implant
0.59 mg Fluocinolone Acetonide implant
Intervention: 0.59 mg Fluocinolone Acetonide implant
Outcomes
Primary Outcomes
Number of Eyes With Inflammation Recurrence
Time Frame: 5 years
Number of eyes with inflammation recurrence
Secondary Outcomes
- Percentage of Eyes With Improvement in Visual Acuity(baseline to 52 weeks)
- Number of Participant's Eye Requiring Adjunctive Therapy(5 years)
- Number of Eyes With Increased Intraocular Pressure(52 weeks)