Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief 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.


Options:
A: Inclusion Criteria:

* 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Any active ocular infections
B: Inclusion Criteria:

* Patient, male or female (under effective contraception if premenopausal) over 18 years old
* Patient affiliated with a social security plan
* Patient able to understand and follow the instructions of the study
* Patient having signed an informed consent
* Patient having a central macular thickness greater than 320μm (Spectral Domain, 270µm Time Domain)
* Patient with an inflammatory macular edema, unilateral or bilateral (in the case of a bilateral inflammatory macular edema, the eye most affected will be treated)

Exclusion Criteria:

* Patient with an infectious uveitis
* Patient with uncontrolled active infection
* Patient receiving an unbalanced general anti-inflammatory and/or immunosuppressive and/or immunomodulatory therapy (recent modification \<1 month)
* Patient having a history of glaucoma and/or ocular hypertension in the eye studied (intraocular pressure (IOP) \> 25 mmHg without antiglaucoma medication or \> 21 mmHg with antiglaucoma combination therapy) and/or cortisone-causing-hypertension not controlled by an antiglaucoma dual therapy
* Patient with uncontrolled diabetes (HbA1c\> 8%) or unbalanced hypertension (Systolic Blood Pressure \> 160 mmHg and/or Diastolic Blood Pressure \> 100mmHg)
* Edematous diabetic maculopathy
* Patient who had received triamcinolone (subconjunctivally or sub-tenon) 3 months before randomization, or 700μg dexamethasone intravitreally 6 months before randomization
* Suspected or active ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, such as active epithelial keratitis with herpes simplex (dendritic keratitis), vaccinia, varicella, mycobacterial infections and mycoses
* History of ocular herpes infection or central serous chorioretinopathy
* Aphakic eye with rupture of the posterior lens capsule
* Eye with implant in the anterior chamber, iris- or transscleral-fixated intraocular implant and rupture of the posterior lens capsule
* Uncontrolled systemic inflammatory disease.
* Known hypersensitivity to the active substance or to one of the excipients of Ozurdex®, Kenacort® or injectable fluorescein
* Pregnant woman or likely to become pregnant or nursing
* Patient participating in another clinical trial
* Adult under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")
C: Inclusion Criteria:

* Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent, non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study, and had 'quiet' eyes at surgery

Exclusion Criteria:

* Coexisting medical or ocular conditions that would interfere with the study results
D: 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

Answer: D