Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: April 2006

Interventions

  • Drug: Fluocinolone Acetonide 0.59mg
    • Fluocinolone Acetonide Intravitreal Implant 0.59 mg
  • Drug: Fluocinolone Acetonide 2.1mg
    • Fluocinolone Acetonide Intravitreal Implant 2.1 mg

Arms, Groups and Cohorts

  • Experimental: Fluocinolone Acetonide 0.59mg
    • Fluocinolone acetonide intravitreal implant 0.59mg
  • Experimental: Fluocinolone Acetonide 2.1mg
    • Fluocinolone acetonide intravitreal implant 2.1mg
  • No Intervention: No Intervention
    • Fellow eye

Clinical Trial Outcome Measures

Primary 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

Secondary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Timothy L Comstock, OD, Study Director, Bausch & Lomb Incorporated

References

Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.