This study will test whether a new corticosteroid implant is more effective for reducing eye inflammation in patients with uveitis than the standard treatment with oral corticosteroids. Uveitis is an inflammation in the eye that, left untreated, can impair vision.

People 13 years of age or older with active, vision-threatening uveitis that is not caused by an infection and that would ordinarily require treatment with an oral corticosteroid may be eligible for this study. Candidates are screened with a medical history, blood tests, measurement of blood pressure, height and weight, bone density scans of the spine and hip, and an eye examination. The eye examination includes a test of vision and eye pressure, photographs of the eye lens, fluorescein angiography (photographs of blood vessels in the back of the eye), and optical coherence tomography. For the fluorescein angiography, a dye is injected through a vein in the arm or hand. It travels through the bloodstream to the blood vessels in the back of the eye. A series of pictures are taken that reveal the location and severity of inflammation in the back of the eye. Optical coherence tomography uses light to measure the thickness of the central part of the retina (back part of the eye) to look for swelling.

Participants are randomly assigned to receive oral corticosteroid treatment or the corticosteroid implant, as follows:

• Corticosteroid implant

Patients receive implants in one or both eyes, depending on whether one or both eyes need treatment. If both eyes are to receive implants, the second surgery is usually scheduled within 2 weeks after the first. The surgery is usually done under local anesthesia, with medication given through a vein to relax the patient and keep him or her comfortable during the procedure. A numbing medicine is injected around the eye to prevent pain. The implant is placed behind the iris (colored part of the eye), and a patch is placed over the eye until the day after the surgery. Patients are examined the day after surgery and once or twice more for checkups. The implant slowly releases a corticosteroid medicine called fluocinolone acetonide. It lasts about 2-1/2 years and can be replaced after that, if needed.

• Oral corticosteroids

Patients assigned to standard therapy take corticosteroids by mouth, with the dose being slowly decreased. If the dose cannot be reduced to a sufficiently low level because the inflammation returns, an immune-modulating drug is added to the treatment. Total treatment time varies, but, because uveitis often recurs, treatment may continue for two years or more.

OR

Patients assigned to standard therapy take corticosteroids by mouth, combined with other immunosuppressive agents, based on the individual patient's condition. The steroid dose is slowly decreased. Total treatment time varies, but, because uveitis often recurs, treatment may continue for two years or more.

In addition to their assigned treatment, patients may receive corticosteroid eye drops, ointments, or injections next to the eye as needed for the most effective control of swelling and inflammation.

Patients have clinic visits at weeks 4 and 12 after enrollment and every 12 weeks after that for up to 4 years. At each visit, patients provide a medical history, have an eye examination, complete questionnaires, have a blood test, and have their blood pressure and weight measured. They have fluorescein angiography and digital imaging of the eyes at weeks 4, 24, and 52 and then once a year. Color photographs of the eye are taken once a year. A scan of the spine and hip bones is done once a year. Visits to treat the uveitis may be required as often as once a month.