Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant
Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-infectious Uveitis
Intervention: Fluocinolone Acetonide 0.59mg (Drug); Fluocinolone Acetonide 2.1mg (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Bausch & Lomb Incorporated Official(s) and/or principal investigator(s): Timothy L Comstock, OD, Study Director, Affiliation: Bausch & Lomb Incorporated
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Related 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.
Starting date: May 2002
Last updated: December 7, 2011
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