Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
Condition: Non-Infectious Uveitis
MeSH terms: Uveitis
Intervention: FAI insert; Sham injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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 with or without anterior uveitis > 1 year duration.

          -  During the 12 months prior to enrollment (Day 1), the study eye has either received
             treatment:

          -  systemic corticosteroid or other systemic therapies given for at least 3 months,
             and/or

          -  at least 2 intra- or peri-ocular injections of corticosteroid for management of
             uveitis

        OR the study eye has experienced recurrence:

          -  at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular
             injection of corticosteroid

          -  At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/HPF and a
             vitreous haze ≤ grade 2.

          -  Visual acuity of study eye is at least 15 letters on the ETDRS chart

          -  Subject is not planning to undergo elective ocular surgery during the study

          -  Subject has ability to understand and sign the Informed Consent Form

          -  Subject is willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures

        Exclusion Criteria

          -  Allergy to fluocinolone acetonide or any component of the FAI insert

          -  History of posterior uveitis only that is not accompanied by vitritis or macular edema

          -  History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze

          -  Uveitis with infectious etiology

          -  Vitreous hemorrhage

          -  Intraocular inflammation associated with a condition other than noninfectious uveitis
             (e.g. intraocular lymphoma)

          -  Ocular malignancy in either eye, including choroidal melanoma

          -  Toxoplasmosis scar in study eye; or scar related to previous viral retinitis

          -  Previous viral retinitis

          -  Current viral diseases of the cornea and conjunctiva including epithelial herpes
             simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial
             infections of the eye or fungal diseases of ocular structure

          -  Media opacity precluding evaluation of retina and vitreous

          -  Peripheral retinal detachment in area of insertion

          -  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)

          -  Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at screening with any
             IOP-lowering pharmacologic agent in the study eye

          -  Chronic hypotony (< 6 mmHg)

          -  Ocular surgery on the study eye within 3 months prior to study Day 1

          -  Capsulotomy in study eye within 30 days prior to study Day 1

          -  Prior intravitreal treatment of study eye with Retisert within 36 months prior to
             study Day 1

          -  Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study
             Day 1

          -  Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months
             prior to study Day 1

          -  Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to
             study Day 1

          -  Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg
             prednisone daily) or chronic systemic immunosuppressive therapy

          -  Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell
             carcinoma), any malignancy receiving treatment, or in remission less than 5 years
             prior to study Day 1

          -  Subjects who test positive for human immune deficiency virus (HIV) or syphilis during
             screening

          -  Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of
             the Investigator, result from infectious mycobacterial uveitis

          -  Systemic infection within 30 days prior to study Day 1

          -  Any severe acute or chronic medical or psychiatric condition that could increase the
             risk associated with study participation or could interfere with the interpretation of
             study results and, in the judgment of the investigator, could make the subject
             inappropriate for entry into this study

          -  Any other systemic or ocular condition which, in the judgment of the investigator,
             could make the subject inappropriate for entry into this study

          -  Treatment with an investigational drug or device within 30 days prior to study 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 this protocol from
             at least 14 days prior to study Day 1 until the Month 12 Visit

          -  Subjects unlikely to comply with the study protocol or who are likely to be lost to
             follow-up within three years