Non-infectious Uveitis
Conditions
Brief summary
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.
Interventions
surgical intravitreal implant of fluocinolone acetonide
Systemic corticosteroids alone or combined with immunosuppressants
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and non-pregnant females at least 6 years of age * History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease * The more severely affected eye having had at least 2 separate recurrences * The more severely affected eye having been treated by systemic therapy for at least one month just before inclusion * Visual acuity (VA) of at least 1.4 logMAR units at enrollment * At time of enrollment, \</=10 anterior chamber cells/HPF and vitrous haze\</= grade 2.
Exclusion criteria
* known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered * history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous * presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP \>25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to \<25 mm Hg * history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze * infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye * ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment * monocularity * AIDS * pregnancy/lactation * potential for noncompliance * or participation in other clinical studies within 1 month of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of uveitis in the study eye. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of recurrences | 33 months |
| Number of recurrences compared to the 52 weeks prior to enrollment | 33 months |
| Change in quality of life indices | 33 months |
| The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline. | 33 months |
| Change in the size, if present at baseline, of the area of CME on fluorescein angiography | 33 months |
| Analysis of safety variables | 33 months |
| Percent of subjects who had at least one recurrence | 33 months |
| Adjunctive treatment required | 33 months |
Outcome results
None listed