Clinical Trial: Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief Summary: 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.
Detailed Summary:
Sponsor: Bausch & Lomb Incorporated
Current Primary Outcome: Recurrence of uveitis before and after implantation. [ Time Frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation ]
Original Primary Outcome:
- 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.
Current Secondary Outcome:
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Results of QOL surveys pre- versus post-implantation [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ]
- 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 ]
- Time to recurrence, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ]
- Post implantation uveitis rate, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ]
Original Secondary Outcome:
- 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
Information By: Bausch & Lomb Incorporated
Dates:
Date Received: December 1, 2006
Date Started: December 2000
Date Completion:
Last Updated: December 7, 2011
Last Verified: December 2011