Intervention: FLUOCINOLONE ACETONIDE
Trial phase: Phase 3
ATC code: C05AA10 | D07AC04 | D07BC02 | D07CC02 | S01BA15 | S01CA10 | S02BA08 | S02CA05
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: FAI Insert Group
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
At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.
Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (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

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 administrations 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

Exclusion Criteria:

Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (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 structures
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 Intraocular pressure (IOP) in the normal range (10-21 mmHg)
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 have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis
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