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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-23

Study Completion Date

2017-08-17

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.

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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.

Conditions

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Non-Infectious Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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FAI Insert administered using the Mk II inserter

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.

Group Type EXPERIMENTAL

FAI Insert administered using the Mk II inserter

Intervention Type DRUG

FAI Insert administered using the Mk I inserter

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.

Group Type ACTIVE_COMPARATOR

FAI Insert administered using the Mk I inserter

Intervention Type DRUG

Interventions

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FAI Insert administered using the Mk II inserter

Intervention Type DRUG

FAI Insert administered using the Mk I inserter

Intervention Type DRUG

Other Intervention Names

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Fluocinolone Acetonide Intravitreal (FAI) Fluocinolone Acetonide Intravitreal (FAI)

Eligibility Criteria

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Inclusion Criteria

1. Male or non-pregnant female at least 18 years of age at time of consent
2. At least one eye has a history of non-infectious uveitis affecting the posterior segment
3. Subject has ability to understand and sign the Informed Consent Form
4. Subject is willing and able to comply with study requirements

Exclusion Criteria

1. Allergy to fluocinolone acetonide or any component of the FAI insert
2. Ocular malignancy in either eye, including choroidal melanoma
3. Uveitis with infectious etiology
4. Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
5. Current mycobacterial infections of the eye or fungal diseases of ocular structures
6. Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV) or syphilis
7. Systemic infection within 30 days prior to study Day 1
8. Peripheral retinal detachment in area of insertion
9. Elevated intraocular pressure (IOP) \> 21 mmHg, or chronic hypotony \< 6 mmHg
10. Concurrent therapy at screening with IOP-lowering pharmacologic agent in the study eye
11. 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)
12. 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)
13. Ocular surgery or capsulotomy performed on the study eye within 30 days prior to study Day 1
14. 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
15. Peri-ocular or subtenon steroid treatment of study eye within 30 days prior to study Day 1
16. Treatment with an investigational drug or device within 30 days prior to study Day 1, except the FAI insert within this protocol
17. 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
18. Any condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No