Non-infectious Uveitis
Conditions
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.
Interventions
DRUGFluocinolone Acetonide 0.59mg
Fluocinolone Acetonide Intravitreal Implant 0.59 mg
Fluocinolone Acetonide Intravitreal Implant 2.1 mg
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
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, * Had clinically 'quiet' eyes at surgery.
Exclusion criteria
* Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 1 year pre-implantation; 3 years post-implantation |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 1 year pre-implantation; 3 years post-implantation |
Outcome results
None listed