Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

Non-infectious Uveitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468871
• Other study ID #: 415-002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 2, 2007
• Last updated: December 7, 2011
• Start date: April 2002
• Est. completion date: June 2006

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non-infectious Uveitis
• Uveitis

Intervention

Drug:
• fluocinolone acetonide intravitreal implant
surgical intravitreal implant of fluocinolone acetonide
• corticosteroids and immunosuppressants
Systemic corticosteroids alone or combined with immunosuppressants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of uveitis in the study eye.		2 years	No
Secondary	The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.		33 months	No
Secondary	Number of recurrences		33 months	No
Secondary	Number of recurrences compared to the 52 weeks prior to enrollment		33 months	No
Secondary	Change in quality of life indices		33 months	No
Secondary	Adjunctive treatment required		33 months	No
Secondary	Change in the size, if present at baseline, of the area of CME on fluorescein angiography		33 months	No
Secondary	Analysis of safety variables		33 months	No
Secondary	Percent of subjects who had at least one recurrence		33 months	No