This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
surgical intravitreal implant of fluocinolone acetonide
Systemic corticosteroids alone or combined with immunosuppressants
Time to first occurrence of uveitis in the study eye.
Time frame: 2 years
The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.
Time frame: 33 months
Number of recurrences
Time frame: 33 months
Number of recurrences compared to the 52 weeks prior to enrollment
Time frame: 33 months
Change in quality of life indices
Time frame: 33 months
Adjunctive treatment required
Time frame: 33 months
Change in the size, if present at baseline, of the area of CME on fluorescein angiography
Time frame: 33 months
Analysis of safety variables
Time frame: 33 months
Percent of subjects who had at least one recurrence
Time frame: 33 months
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