Intervention: SULFISOXAZOLE
Trial phase: Phase 3
ATC code: G01AE10 | J01EB05 | S01AB02
SMILES: Cc1noc(NS(=O)(=O)c2ccc(N)cc2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: FAI insert (0.18 mg fluocinolone acetonide)

FAI insert
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