Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

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. Identifier: NCT00456482
Recruitment Status : Terminated (SARS epidemic in Asia and Canada)
First Posted : April 5, 2007
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Non-infectious Uveitis Drug: Fluocinolone Acetonide 0.59mg Drug: Fluocinolone Acetonide 2.1mg Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2002
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT00456482

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

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00456482     History of Changes
Other Study ID Numbers: 415-004
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

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