Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Noninfectious Posterior Uveitis
Intervention: fluocinolone acetonide intravitreal implant (Drug); Fluocinolone acetonide 2.1mg (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Bausch & Lomb Incorporated Official(s) and/or principal investigator(s): Thomas A Crescuillo, 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 (FA) 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 & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) 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 (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Recurrence of uveitis before and after implantation.
Secondary outcome: Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes. The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation) Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes) Results of QOL surveys pre- versus post-implantation Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) Time to recurrence, between treatment group comparison Post implantation uveitis rate, between treatment group comparison
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, and had 'quiet'
eyes at surgery
Exclusion Criteria:
- Coexisting medical or ocular conditions that would interfere with the study results
Locations and Contacts
Duke Eye Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: December 2000
Last updated: December 7, 2011
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