Phase 4 N=21 Treatment

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

Uveitis

Bottom Line

View on ClinicalTrials.gov: NCT00543296 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Number of Eyes With Inflammation Recurrence — 1 eye with inflammation

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 0.59 mg Fluocinolone Acetonide implant (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Duke University
Primary completion: Jul 2007

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	—

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.

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

View full record on ClinicalTrials.gov →

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.