Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

This study has been terminated.
(SARS epidemic in Asia and Canada)
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: April 3, 2007
Last updated: December 7, 2011
Last verified: December 2011

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.

Condition Intervention Phase
Non-infectious Uveitis
Drug: Fluocinolone Acetonide 0.59mg
Drug: Fluocinolone Acetonide 2.1mg
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye. [ Time Frame: 1 year pre-implantation; 3 years post-implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys. [ Time Frame: 1 year pre-implantation; 3 years post-implantation ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: May 2002
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluocinolone Acetonide 0.59mg
Fluocinolone acetonide intravitreal implant 0.59mg
Drug: Fluocinolone Acetonide 0.59mg
Fluocinolone Acetonide Intravitreal Implant 0.59 mg
Experimental: Fluocinolone Acetonide 2.1mg
Fluocinolone acetonide intravitreal implant 2.1mg
Drug: Fluocinolone Acetonide 2.1mg
Fluocinolone Acetonide Intravitreal Implant 2.1 mg
No Intervention: No Intervention
Fellow eye


Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,
  • Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,
  • Had clinically 'quiet' eyes at surgery.

Exclusion Criteria:

  • Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.
  Contacts and Locations
Please refer to this study by its identifier: NCT00456482

Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Timothy L Comstock, OD Bausch & Lomb Incorporated
  More Information

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00456482     History of Changes
Other Study ID Numbers: 415-004
Study First Received: April 3, 2007
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uveal Diseases
Eye Diseases
Retinal Diseases
Choroid Diseases
Uveitis, Posterior
Fluocinolone Acetonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses processed this record on April 15, 2014