Phase 4
Completed N=21
Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Source: ClinicalTrials.gov NCT00543296 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Number of Eyes With Inflammation Recurrence — 1 eye with inflammation
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eyes With Inflammation Recurrence |
1 | — |
| SECONDARY Percentage of Eyes With Improvement in Visual Acuity |
45 | — |
| SECONDARY Number of Participant's Eye Requiring Adjunctive Therapy |
12; 7; 1; 4 | — |
| SECONDARY Number of Eyes With Increased Intraocular Pressure |
2 | — |
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
Data sourced from ClinicalTrials.gov (NCT00543296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.