Re-Implantation of a Fluocinolone Acetonide Implant for Non-Infectious Uveitis Affecting the Posterior Segment - Full Text View

Sponsors and Collaborators:	Duke University Bausch & Lomb, Inc.
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00543296

Purpose

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.

Condition	Intervention	Phase
Uveitis	Drug: Fluocinolone acetonide sustained drug delivery implant	Phase IV

Drug Information available for: Fluocinolone Fluocinolone acetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title:	Re-Implantation of a Fluocinolone Acetonide Implant for Non-Infectious Uveitis Affecting the Posterior Segment

Further study details as provided by Duke University:

Primary Outcome Measures:

Inflammation recurrence [ Time Frame: 5 years ]

Secondary Outcome Measures:

Visual Acuity [ Time Frame: 5 years ]
Ancillary Medications [ Time Frame: 5 years ]
Intraocular Pressure [ Time Frame: 5 years ]
Adverse Events [ Time Frame: 5 years ]

Estimated Enrollment:	30
Study Start Date:	January 2007

Intervention Details:

Intravitreal implantation of implant

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543296

Contacts

Contact: Glenn J Jaffe, MD	(919) 684 4458	jaffe001@mc.duke.edu
Contact: Brenda Branchaud	(919) 681 1569	Branc016@mc.duke.edu

Locations

United States, North Carolina
Duke University Eye Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Glenn Jaffe, MD 919-684-4458 jaffe001@mc.duke.edu
Contact: Brenda Branchaud (919) 681 1569 branc016@mc.duke.edu
Principal Investigator: Glenn Jaffe, MD

Sponsors and Collaborators

Duke University

Bausch & Lomb, Inc.

Investigators

Principal Investigator:

Glenn J Jaffe, MD

Duke University

More Information

Study ID Numbers:	1622
Study First Received:	October 11, 2007
Last Updated:	October 11, 2007
ClinicalTrials.gov Identifier:	NCT00543296
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

uveitis
CME
fluocinolone acetonide
non-infectious uveitis affecting the posterior segment

Study placed in the following topic categories:

Fluocinolone Acetonide
Uveitis
Eye Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Uveal Diseases
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009