Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

Phase 2

Completed

• Conditions: Non-infectious Uveitis
• Interventions: Drug: corticosteroids and immunosuppressants; Drug: fluocinolone acetonide intravitreal implant

• Registration Number: NCT00468871
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2007-05-02
• Study First Submitted QC: 2007-05-02
• Study First Posted: 2007-05-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	corticosteroids and immunosuppressants	Standard of Care
Fluocinolone acetonide	fluocinolone acetonide intravitreal implant	Intravitreal fluocinolone acetonide implant

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of uveitis in the study eye.	2 years

Secondary Outcome Measures

Name	Time	Method
Adjunctive treatment required	33 months
Number of recurrences	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
Percent of subjects who had at least one recurrence	33 months
Analysis of safety variables	33 months
Number of recurrences compared to the 52 weeks prior to enrollment	33 months
Change in the size, if present at baseline, of the area of CME on fluorescein angiography	33 months