Status:
COMPLETED
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Non-infectious Uveitis
Eligibility:
All Genders
6+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00468871
Start Date
April 1 2002
End Date
June 1 2006
Last Update
December 8 2011
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