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

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00543296
First received: October 11, 2007
Last updated: June 9, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Number of eyes with inflammation recurrence


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

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

  • Number of Eyes With Increased Intraocular Pressure [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

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

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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00543296     History of Changes
Other Study ID Numbers: Pro00013641
Study First Received: October 11, 2007
Results First Received: August 8, 2013
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Chorioretinitis
Uveitis
Choroid Diseases
Choroiditis
Eye Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014