Back to resultsSafety and Efficacy of Fluocinolone Acetonide Intravitreal Implant
Primary Purpose
Non-infectious Uveitis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fluocinolone Acetonide 0.59mg
Fluocinolone Acetonide 2.1mg
Sponsored by
About this trial
This is an interventional treatment trial for Non-infectious Uveitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Fluocinolone Acetonide 0.59mg
Fluocinolone Acetonide 2.1mg
No Intervention
Arm Description
Fluocinolone acetonide intravitreal implant 0.59mg
Fluocinolone acetonide intravitreal implant 2.1mg
Fellow eye
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
NCT ID
NCT00456482
First Posted
April 3, 2007
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00456482
Brief Title
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant
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 Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
SARS epidemic in Asia and Canada
Study Start Date
May 2002 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-infectious Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluocinolone Acetonide 0.59mg
Arm Type
Experimental
Arm Description
Fluocinolone acetonide intravitreal implant 0.59mg
Arm Title
Fluocinolone Acetonide 2.1mg
Arm Type
Experimental
Arm Description
Fluocinolone acetonide intravitreal implant 2.1mg
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Fellow eye
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide 0.59mg
Intervention Description
Fluocinolone Acetonide Intravitreal Implant 0.59 mg
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide 2.1mg
Intervention Description
Fluocinolone Acetonide Intravitreal Implant 2.1 mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy L Comstock, OD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16690128
Citation
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. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
Results Reference
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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant
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