Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis

Study Overview
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Brief Summary
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This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.

Detailed Description
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This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the MK II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.

Official Title
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A Controlled, Multi-Center Study of the Utilization and Safety of the MkII Inserter and the Safety of the FAI Insert in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.

Conditions
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Non-Infectious Uveitis

Intervention / Treatment
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* Drug: FAI Insert administered using the Mk II inserter
* Drug: FAI Insert administered using the Mk I inserter


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 At least one eye has a history of non-infectious uveitis affecting the posterior segment Subject has ability to understand and sign the Informed Consent Form Subject is willing and able to comply with study requirements Exclusion Criteria: Allergy to fluocinolone acetonide or any component of the FAI insert Ocular malignancy in either eye, including choroidal melanoma Uveitis with infectious etiology Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella Current mycobacterial infections of the eye or fungal diseases of ocular structures Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV) or syphilis Systemic infection within 30 days prior to study Day 1 Peripheral retinal detachment in area of insertion Elevated intraocular pressure (IOP) > 21 mmHg, or chronic hypotony < 6 mmHg Concurrent therapy at screening with IOP-lowering pharmacologic agent in the study eye Current diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg) Known history of clinically significant IOP elevation in response to steroid treatment in either eye, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg) Ocular surgery or capsulotomy performed on the study eye within 30 days prior to study Day 1 Intravitreal treatment of study eye: with FAI insert within 36 months prior to study Day 1;with Retisert within 30 months prior to study Day 1; with Ozurdex within 90 days prior to study Day 1; or with Triesence or Trivaris within 30 days prior to study Day 1 Peri-ocular or subtenon steroid treatment of study eye within 30 days prior to study Day 1 Treatment with an investigational drug or device within 30 days prior to study Day 1, except the FAI insert within this protocol Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit Any condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAI Insert administered using the Mk II inserter<br>The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. | Drug: FAI Insert administered using the Mk II inserter<br> <br> * Other names: Fluocinolone Acetonide Intravitreal (FAI);|
| Active Comparator: FAI Insert administered using the Mk I inserter<br>The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana. | Drug: FAI Insert administered using the Mk I inserter<br> <br> * Other names: Fluocinolone Acetonide Intravitreal (FAI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | The primary utilization endpoint was defined as the proportion of intravitreal insertion procedures that were assessed by the investigator as satisfactory. A satisfactory procedure was defined as one receiving a score from the Investigator as either Very Easy, Easy, or Routine. | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | To assess the safety of the FAI insert during 12 months following treatment reported as percentages. | Month 12 |