Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI)

Study Overview
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Brief Summary
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A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.

Detailed Description
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This is a phase 3, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for one year following treatment.

Official Title
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A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Conditions
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Uveitis, Uveitis, Posterior, Uveitis, Intermediate

Intervention / Treatment
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* Drug: Sham Injector
* Drug: FAI Insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female at least 18 years of age at time of consent One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye (intermediate, posterior, or panuveitis) with or without anterior uveitis > 1 year duration. During the 52 weeks prior to enrollment (Day 1), the study eye has either received treatment systemic corticosteroid or other systemic therapies given for at least 12 weeks, and/or at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis OR the study eye has experienced recurrence recurrences of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid. Subject is not planning to undergo elective ocular surgery during the study Subject has ability to understand and sign the Informed Consent Form (ICF). Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: History of posterior uveitis only that is not accompanied by vitritis or macular edema. History of iritis only associated with no vitreous cells, anterior chamber cells, or vitreous haze at Day 1. Uveitis with infectious etiology. Vitreous hemorrhage. Intraocular inflammation associated with a condition other than noninfectious uveitis (eg, intraocular lymphoma). Uveitis limited to the anterior segment, ie, anterior uveitis only. Ocular malignancy in either eye, including choroidal melanoma. Previous viral retinitis. Requirement for chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy. History of certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to Day 1. Positive test for human immunodeficiency virus (HIV) or syphilis during Screening. Mycobacterial uveitis or chorioretinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis. Systemic infection within 30 days prior to Day 1. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to Day 1 until the 52-week Visit. Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Sham Comparator: Sham Comparator<br>sham injection | Drug: Sham Injector<br>* Sham injection<br>* Other names: Sham Comparator;|
| Active Comparator: FAI insert (0.05 mg fluocinolone acetonide)<br>FAI insert (0.05 mg fluocinolone acetonide) | Drug: FAI Insert<br>* FAI insert<br>* Other names: Active Drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who have a recurrence of uveitis in the study eye within 24 weeks (6 months) after receiving study treatment |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EyePoint, Uveitis, EYP-2102