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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

Primary Purpose

Noninfectious Posterior Uveitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fluocinolone acetonide intravitreal implant
Fluocinolone acetonide 2.1mg
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Noninfectious Posterior Uveitis

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Eye Center

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 ocular implant 0.59mg

Fluocinolone acetonide ocular implant 2.1mg

Fellow eye

Outcomes

Primary Outcome Measures

Recurrence of uveitis before and after implantation.

Secondary Outcome Measures

Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.
Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes.
The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation)
Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes)
Results of QOL surveys pre- versus post-implantation
Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes)
Time to recurrence, between treatment group comparison
Post implantation uveitis rate, between treatment group comparison

Full Information

First Posted
December 1, 2006
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00407082
Brief Title
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noninfectious Posterior Uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluocinolone acetonide 0.59mg
Arm Type
Experimental
Arm Description
Fluocinolone acetonide ocular implant 0.59mg
Arm Title
Fluocinolone acetonide 2.1mg
Arm Type
Experimental
Arm Description
Fluocinolone acetonide ocular implant 2.1mg
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Fellow eye
Intervention Type
Drug
Intervention Name(s)
fluocinolone acetonide intravitreal implant
Intervention Description
Fluocinolone acetonide ocular implant 0.59mg
Intervention Type
Drug
Intervention Name(s)
Fluocinolone acetonide 2.1mg
Intervention Description
Fluocinolone acetonide ocular implant 2.1mg
Primary Outcome Measure Information:
Title
Recurrence of uveitis before and after implantation.
Time Frame
34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Results of QOL surveys pre- versus post-implantation
Time Frame
34 weeks, 1 year, 2 years and 3 years post-implantation
Title
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
Title
Time to recurrence, between treatment group comparison
Time Frame
34 weeks, 1 year, 2 years and 3 years post-implantation
Title
Post implantation uveitis rate, between treatment group comparison
Time Frame
34 weeks, 1 year, 2 years and 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, and had 'quiet' eyes at surgery Exclusion Criteria: Coexisting medical or ocular conditions that would interfere with the study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Crescuillo
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

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
result
PubMed Identifier
18779477
Citation
Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008 Sep;126(9):1191-201. doi: 10.1001/archopht.126.9.1191.
Results Reference
derived

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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

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