Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

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

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 Overview

• Status: Completed
• Conditions: Non-infectious Uveitis
• Intervention / Treatment: Drug: fluocinolone acetonide intravitreal implant; Drug: corticosteroids and immunosuppressants

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluocinolone acetonide; Intravitreal fluocinolone acetonide implant	Drug: fluocinolone acetonide intravitreal implant; surgical intravitreal implant of fluocinolone acetonide
Active Comparator: Standard care; Standard of Care	Drug: corticosteroids and immunosuppressants; Systemic corticosteroids alone or combined with immunosuppressants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first occurrence of uveitis in the study eye.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.	33 months
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
Adjunctive treatment required	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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Carlos Pavesio, MD, Medical Retina Service/Moorfields Eye Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: May 2, 2007
• First Submitted That Met QC Criteria: May 2, 2007
• First Posted (Estimate): May 3, 2007

Study Record Updates

• Last Update Posted (Estimate): December 8, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluocinolone Acetonide; Immunosuppressive Agents
• Other Study ID Numbers: 415-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No