Re-Implantation of a Fluocinolone Acetonide Implant for Non-Infectious Uveitis Affecting the Posterior Segment
Information source: Duke University
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uveitis
Intervention: Fluocinolone acetonide sustained drug delivery implant (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Glenn J Jaffe, MD, Principal Investigator, Affiliation: Duke University
Overall contact:
Glenn J Jaffe, MD, Phone: (919) 684 4458, Email: jaffe001@mc.duke.edu
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: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Inflammation recurrence
Secondary outcome: Visual AcuityAncillary Medications Intraocular Pressure Adverse Events
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
Glenn J Jaffe, MD, Phone: (919) 684 4458, Email: jaffe001@mc.duke.edu
Duke University Eye Center, Durham, North Carolina 27710, United States; Recruiting
Glenn Jaffe, MD, Phone: 919-684-4458, Email: jaffe001@mc.duke.edu
Brenda Branchaud, Phone: (919) 681 1569, Email: branc016@mc.duke.edu
Glenn Jaffe, MD, Principal Investigator
Additional Information
Starting date: January 2007
Last updated: October 11, 2007
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