Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

NCT ID: NCT00468871

Last Updated: 2011-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2006-06-30

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.

Conditions

Non-infectious Uveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluocinolone acetonide

Intravitreal fluocinolone acetonide implant

Group Type: EXPERIMENTAL

fluocinolone acetonide intravitreal implant

Intervention Type: DRUG

surgical intravitreal implant of fluocinolone acetonide

Standard care

Standard of Care

Group Type: ACTIVE_COMPARATOR

corticosteroids and immunosuppressants

Intervention Type: DRUG

Systemic corticosteroids alone or combined with immunosuppressants

Interventions

fluocinolone acetonide intravitreal implant

surgical intravitreal implant of fluocinolone acetonide

Intervention Type: DRUG

corticosteroids and immunosuppressants

Systemic corticosteroids alone or combined with immunosuppressants

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Pavesio, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Retina Service/Moorfields Eye Hospital

References

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.

Reference Type: BACKGROUND

PMID: 16690128 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20079922 (View on PubMed)

Other Identifiers

415-002

Identifier Type: -

Identifier Source: org_study_id