Noninfectious Posterior Uveitis
Conditions
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.
Interventions
Fluocinolone acetonide ocular implant 0.59mg
Fluocinolone acetonide ocular implant 2.1mg
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
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, and had 'quiet' eyes at surgery
Exclusion criteria
* Coexisting medical or ocular conditions that would interfere with the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of uveitis before and after implantation. | 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation |
Secondary
| Measure | Time frame |
|---|---|
| Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes. | 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) | 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) | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes. | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Time to recurrence, between treatment group comparison | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Post implantation uveitis rate, between treatment group comparison | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Results of QOL surveys pre- versus post-implantation | 34 weeks, 1 year, 2 years and 3 years post-implantation |
Countries
United States
Outcome results
None listed