Clinical trial NCT00468871: Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
Official title: A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-infectious Uveitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to first occurrence of uveitis in the study eye.
timeFrame: 2 years
Secondary outcomes:
measure: The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.
timeFrame: 33 months
measure: Number of recurrences
timeFrame: 33 months
measure: Number of recurrences compared to the 52 weeks prior to enrollment
timeFrame: 33 months
measure: Change in quality of life indices
timeFrame: 33 months
measure: Adjunctive treatment required
timeFrame: 33 months
measure: Change in the size, if present at baseline, of the area of CME on fluorescein angiography
timeFrame: 33 months
measure: Analysis of safety variables
timeFrame: 33 months
measure: Percent of subjects who had at least one recurrence
timeFrame: 33 months
Other outcomes:
Locations:
Study officials:
affiliation: Medical Retina Service/Moorfields Eye Hospital
name: Carlos Pavesio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
citation: Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW; Fluocinolone Acetonide Study Group. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010 Mar;117(3):567-75, 575.e1. doi: 10.1016/j.ophtha.2009.11.027. Epub 2010 Jan 15.