Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis
Condition: Non-Infectious Uveitis
MeSH terms: Uveitis
Intervention: FAI Insert administered using the Mk II inserter; FAI Insert administered using the Mk I inserter
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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