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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


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


Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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