Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uveitis
Intervention: 0.59 mg Fluocinolone Acetonide implant (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Glenn J Jaffe, MD, Principal Investigator, Affiliation: Duke University
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.
Clinical Details
Official title: Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Eyes With Inflammation Recurrence
Secondary outcome: Percentage of Eyes With Improvement in Visual AcuityNumber of Participant's Eye Requiring Adjunctive Therapy Number of Eyes With Increased Intraocular Pressure
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
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Duke University Eye Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: March 2004
Last updated: March 12, 2015
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