Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants - Tabular View

Tracking Information

First Received Date ^ICMJE

December 1, 2006

Last Updated Date

May 14, 2009

Start Date ^ICMJE

December 2000

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Recurrence of uveitis before and after implantation. [ Time Frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Recurrence of uveitis before and after implantation.
Uveitis recurrent rates were determined for the 1-year period prior to, and the 34-week, 1-year , 2-year and 3-year periods following implantation.

Change History

Complete list of historical versions of study NCT00407082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes. [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes. [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Results of QOL surveys pre- versus post-implantation [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Time to recurrence, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Post implantation uveitis rate, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Between dose comparisons of the rate of uveitis recurrence post-implantation
Within-subject comparison of Study eye to Fellow eye for recurrence of uveitis post-implantation
Time to first post-implantation recurrence of uveitis
The need for adjunctive uveitis treatment for the study eye (pre- versus post-implantation)
Reduction in the area of cystoid macular edema (CME)
Results of QOL surveys pre- versus post-implantation

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Historical Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Noninfectious Posterior Uveitis

Intervention ^ICMJE

Drug: fluocinolone acetonide intravitreal implant
Drug: Fluocinolone acetonide

Study Arms / Comparison Groups

Experimental: Fluocinolone acetonide implant 0.59mg
Experimental: Fluocinolone acetonide implant 2.1mg
No Intervention: Fellow eye

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

278

Completion Date

September 2005

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00407082

Responsible Party

Timothy Comstock, Bausch & Lomb Incorporated

Study ID Numbers ^ICMJE

415-001

Study Sponsor ^ICMJE

Bausch & Lomb, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Thomas A Crescuillo

Bausch & Lomb, Inc.

Information Provided By

Bausch & Lomb, Inc.

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP