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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00407082
First received: December 1, 2006
Last updated: December 7, 2011
Last verified: December 2011
History of Changes

December 1, 2006
December 7, 2011
December 2000
September 2005   (final data collection date for primary outcome measure)
Recurrence of uveitis before and after implantation. [ Time Frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Recurrence of uveitis before and after implantation.
  • Uveitis recurrent rates were determined for the 1-year period prior to, and the 34-week, 1-year , 2-year and 3-year periods following implantation.
Complete list of historical versions of study NCT00407082 on ClinicalTrials.gov Archive Site
  • Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes. [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes. [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Results of QOL surveys pre- versus post-implantation [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Time to recurrence, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Post implantation uveitis rate, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
  • Between dose comparisons of the rate of uveitis recurrence post-implantation
  • Within-subject comparison of Study eye to Fellow eye for recurrence of uveitis post-implantation
  • Time to first post-implantation recurrence of uveitis
  • The need for adjunctive uveitis treatment for the study eye (pre- versus post-implantation)
  • Reduction in the area of cystoid macular edema (CME)
  • Results of QOL surveys pre- versus post-implantation
Not Provided
Not Provided
 
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) 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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Noninfectious Posterior Uveitis
  • Drug: fluocinolone acetonide intravitreal implant
    Fluocinolone acetonide ocular implant 0.59mg
  • Drug: Fluocinolone acetonide 2.1mg
    Fluocinolone acetonide ocular implant 2.1mg
  • Experimental: Fluocinolone acetonide 0.59mg
    Fluocinolone acetonide ocular implant 0.59mg
    Intervention: Drug: fluocinolone acetonide intravitreal implant
  • Experimental: Fluocinolone acetonide 2.1mg
    Fluocinolone acetonide ocular implant 2.1mg
    Intervention: Drug: Fluocinolone acetonide 2.1mg
  • No Intervention: No intervention
    Fellow eye

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
September 2005
September 2005   (final data collection date for primary outcome measure)

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, and had 'quiet' eyes at surgery

Exclusion Criteria:

  • Coexisting medical or ocular conditions that would interfere with the study results
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407082
415-001
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Thomas A Crescuillo Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP