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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543296
First Posted: October 12, 2007
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Duke University
  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: 0.59 mg Fluocinolone Acetonide implant Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of Eyes With Inflammation Recurrence [ Time Frame: 5 years ]
    Number of eyes with inflammation recurrence


Secondary Outcome Measures:
  • Percentage of Eyes With Improvement in Visual Acuity [ Time Frame: baseline to 52 weeks ]
    Visual acuity was improved by two or more lines from baseline.

  • Number of Participant's Eye Requiring Adjunctive Therapy [ Time Frame: 5 years ]
    Adjunctive Therapy needed to control inflammation in the implanted eye

  • Number of Eyes With Increased Intraocular Pressure [ Time Frame: 52 weeks ]

Enrollment: 21
Study Start Date: March 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.59 mg Fluocinolone Acetonide implant
0.59 mg Fluocinolone Acetonide implant
Drug: 0.59 mg Fluocinolone Acetonide implant
0.59 mg Fluocinolone Acetonide implant
Other Name: Retisert

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543296


Locations
United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Glenn J Jaffe, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00543296     History of Changes
Other Study ID Numbers: Pro00013641
First Submitted: October 11, 2007
First Posted: October 12, 2007
Results First Submitted: August 8, 2013
Results First Posted: July 9, 2014
Last Update Posted: March 31, 2015
Last Verified: June 2014

Keywords provided by Duke University:
uveitis
Cystoid Macular Edema (CME)
fluocinolone acetonide
non-infectious uveitis affecting the posterior segment

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs