Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Noninfectious Posterior Uveitis

Intervention / Treatment
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* Drug: fluocinolone acetonide intravitreal implant
* Drug: Fluocinolone acetonide 2.1mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluocinolone acetonide 0.59mg<br>Fluocinolone acetonide ocular implant 0.59mg | Drug: fluocinolone acetonide intravitreal implant<br>* Fluocinolone acetonide ocular implant 0.59mg<br>|
| Experimental: Fluocinolone acetonide 2.1mg<br>Fluocinolone acetonide ocular implant 2.1mg | Drug: Fluocinolone acetonide 2.1mg<br>* Fluocinolone acetonide ocular implant 2.1mg<br>|
| No Intervention: No intervention<br>Fellow eye | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes. |  | 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. |  | 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) |  | 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) |  | 34 weeks, 1 year, 2 years and 3 years post-implantation | 
| Results of QOL surveys pre- versus 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) |  | 34 weeks, 1 year, 2 years and 3 years post-implantation | 
| Time to recurrence, between treatment group comparison |  | 34 weeks, 1 year, 2 years and 3 years post-implantation | 
| Post implantation uveitis rate, between treatment group comparison |  | 34 weeks, 1 year, 2 years and 3 years post-implantation |