Please select the eligibility criteria that correspond to the clinical trial below.
Title: Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome
Brief Summary: The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects.

Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision.

There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.


Options:
A: Inclusion: Persistent macular edema associated with diabetic retinopathy, uveitis, retinal vein occlusion, or Irvine-Gass syndrome, persisting at least 90 days after laser treatment or medical management by a physician.

Exclusion: Females who are pregnant or lactating, and females of childbearing potential not using adequate birth control for the duration of the study. Any intraocular procedures or laser treatment less than 90 days before enrollment.
B: 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
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:

* Males and non-pregnant females at least 6 years of age
* History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease
* The more severely affected eye having had at least 2 separate recurrences
* The more severely affected eye having been treated by systemic therapy for at least one month just before inclusion
* Visual acuity (VA) of at least 1.4 logMAR units at enrollment
* At time of enrollment, \</=10 anterior chamber cells/HPF and vitrous haze\</= grade 2.

Exclusion Criteria:

* known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered
* history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous
* presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP \>25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to \<25 mm Hg
* history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze
* infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye
* ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment
* monocularity
* AIDS
* pregnancy/lactation
* potential for noncompliance
* or participation in other clinical studies within 1 month of enrollment.

Answer: A