Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

Non-infectious Uveitis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00456482
• Other study ID #: 415-004
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 3, 2007
• Last updated: December 7, 2011
• Start date: May 2002
• Est. completion date: April 2006

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 239
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,

• Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,

• Had clinically 'quiet' eyes at surgery.

Exclusion Criteria:

• Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non-infectious Uveitis
• Uveitis

Intervention

Drug:
• Fluocinolone Acetonide 0.59mg
Fluocinolone Acetonide Intravitreal Implant 0.59 mg
• Fluocinolone Acetonide 2.1mg
Fluocinolone Acetonide Intravitreal Implant 2.1 mg

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	Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.		1 year pre-implantation; 3 years post-implantation	No
Secondary	Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys.		1 year pre-implantation; 3 years post-implantation	No