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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


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.


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,

- 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

Page last updated: August 23, 2015

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