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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


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 Acuity

Number 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


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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