Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy - Full Text View

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00468871

Purpose

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.

Condition	Intervention	Phase
Non-Infectious Uveitis	Drug: fluocinolone acetonide intravitreal implant Drug: corticosteroids and immunosuppressants	Phase II Phase III

Drug Information available for: Fluocinolone acetonide Fluocinolone Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Time to first occurrence of uveitis in the study eye. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline. [ Time Frame: 33 months ] [ Designated as safety issue: No ]
Number of recurrences [ Time Frame: 33 months ] [ Designated as safety issue: No ]
Number of recurrences compared to the 52 weeks prior to enrollment [ Time Frame: 33 months ] [ Designated as safety issue: No ]
Change in quality of life indices [ Time Frame: 33 months ] [ Designated as safety issue: No ]
Adjunctive treatment required [ Time Frame: 33 months ] [ Designated as safety issue: No ]
Change in the size, if present at baseline, of the area of CME on fluorescein angiography [ Time Frame: 33 months ] [ Designated as safety issue: No ]
Analysis of safety variables [ Time Frame: 33 months ] [ Designated as safety issue: No ]
Percent of subjects who had at least one recurrence [ Time Frame: 33 months ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	April 2002
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intravitreal fluocinolone acetonide implant	Drug: fluocinolone acetonide intravitreal implant surgical intravitreal implant of fluocinolone acetonide
2: Active Comparator Standard of Care	Drug: corticosteroids and immunosuppressants Systemic corticosteroids alone or combined with immunosuppressants

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468871

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Principal Investigator:

Carlos Pavesio, MD

Medical Retina Service/Moorfields Eye Hospital

More Information

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. Epub 2006 May 9.

Responsible Party:	Bausch & Lomb Incorporated ( Marcia de Souza Lima, MD )
Study ID Numbers:	415-002
Study First Received:	May 2, 2007
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00468871 History of Changes
Health Authority:	European Union: European Medicines Agency

Study placed in the following topic categories:

Anti-Inflammatory Agents
Immunologic Factors
Fluocinolone Acetonide
Uveitis
Hormone Antagonists

Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Immunosuppressive Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Uveal Diseases
Immunologic Factors
Fluocinolone Acetonide
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Immunosuppressive Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Uveitis
Therapeutic Uses

ClinicalTrials.gov processed this record on May 06, 2009