This study will investigate the safety and effectiveness of the drug Leflunomide to treat
uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide
suppresses immune system activity and has been shown to control autoimmune diseases, such as
arthritis (joint inflammation), in animals. It has also improved symptoms in patients with
rheumatoid arthritis, and the Food and Drug Administration has approved it for treating
patients with this disease. Eye and joint inflammation may have similar causes, and medicines
for arthritis often help patients with eye inflammation. This study will examine whether
Leflunomide can help patients with uveitis.
Patients with uveitis who are not responding well to steroid treatment and patients who have
side effects from other medicines used to treat uveitis (such as cyclosporine,
cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible
side effects of these medicines may be eligible for this study. Candidates will be screened
with a medical history, physical examination, blood test and eye examination. The eye exam
includes a check of vision and eye pressure, examination of the back of the eye (retina) with
an ophthalmoscope and the front of the eye with a microscope. They will also undergo a
procedure called fluorescein angiography to look at the blood vessels of the eye. A dye
called sodium fluorescein is injected into the bloodstream through a vein. After the dye
reaches the blood vessels of the eye, photographs are taken of the retina.
Study participants will be divided into two groups. One group will take 100 milligrams of
Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other
group will take a placebo-a pill that looks like the Leflunomide pill but does not contain
the medicine. All patients in both groups will also take prednisone. Patients will have
follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each
follow-up visit will include a repeat of the screening exams and an evaluation of side
effects or discomfort from the medicine. Those who do well and want to continue their
assigned treatment after 6 months can continue that treatment for another 6 months and will
have follow-up exams at months 9 and 12.