Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

December 7, 2011 updated by: Bausch & Lomb Incorporated

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 2
  • Phase 3

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,
  • Had clinically 'quiet' eyes at surgery.

Exclusion Criteria:

  • Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.

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 intravitreal implant 0.59mg
Drug: Fluocinolone Acetonide 0.59mg
Fluocinolone Acetonide Intravitreal Implant 0.59 mg
Experimental: Fluocinolone Acetonide 2.1mg
Fluocinolone acetonide intravitreal implant 2.1mg
Drug: Fluocinolone Acetonide 2.1mg
Fluocinolone Acetonide Intravitreal Implant 2.1 mg
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. 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.
Time Frame: 1 year pre-implantation; 3 years post-implantation
1 year pre-implantation; 3 years post-implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 1 year pre-implantation; 3 years post-implantation
1 year pre-implantation; 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: Timothy L Comstock, OD, 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

May 1, 2002

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

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

  • 415-004

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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