Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

December 7, 2011 updated by: Bausch & Lomb Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluocinolone acetonide 0.59mg
Fluocinolone acetonide ocular implant 0.59mg
Drug: fluocinolone acetonide intravitreal implant
Fluocinolone acetonide ocular implant 0.59mg
Experimental: Fluocinolone acetonide 2.1mg
Fluocinolone acetonide ocular implant 2.1mg
Drug: Fluocinolone acetonide 2.1mg
Fluocinolone acetonide ocular implant 2.1mg
No Intervention: No intervention
Fellow eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of uveitis before and after implantation.
Time Frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation
34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
34 weeks, 1 year, 2 years and 3 years post-implantation
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
34 weeks, 1 year, 2 years and 3 years post-implantation
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
34 weeks, 1 year, 2 years and 3 years post-implantation
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
34 weeks, 1 year, 2 years and 3 years post-implantation
Results of QOL surveys pre- versus post-implantation
Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
34 weeks, 1 year, 2 years and 3 years post-implantation
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
34 weeks, 1 year, 2 years and 3 years post-implantation
Time to recurrence, between treatment group comparison
Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
34 weeks, 1 year, 2 years and 3 years post-implantation
Post implantation uveitis rate, between treatment group comparison
Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
34 weeks, 1 year, 2 years and 3 years post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Thomas A Crescuillo, Bausch & Lomb Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

December 1, 2006

First Submitted That Met QC Criteria

December 1, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 415-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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