Leflunomide to Treat Uveitis

Launched by NATIONAL EYE INSTITUTE (NEI) · Nov 3, 1999

Keywords

ClinConnect Summary

Although corticosteroids remain the mainstay of therapy for intraocular inflammation, many patients are intolerant or resistant to corticosteroid therapy. In these patients, other immunosuppressive agents have been employed to control potentially sight-threatening uveitis. Nevertheless, ideal therapy for these patients remains elusive, and there is a need for new immunosuppressive agents with varying modes of action and side effect profiles. Leflunomide, an isoxazole derivative, has profound immunosuppressive activity. Leflunomide inhibits autoimmune disease in animal models and has been us...

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • Diagnosis of current intermediate or posterior uveitis, or panuveitis.
• • Current evidence of active intraocular inflammation based on the presence of vitreous haze, active retinal lesions, retinal vasculitis, or cystoid macular edema.
• • 16 years of age or older.
• • Visual acuity of 73 letters or fewer (Snellen equivalent: 20/40 or worse) in at least one eye.
• • The ability to understand and sign an informed consent form which must be obtained prior to randomization.
• • The diagnosis of intermediate uveitis requires the presence of vitritis and either peripheral retinal vascular disease, cellular debris in the inferior vitreous (vitreous snowballs), exudate on the pars plana, or peripheral retinal infiltrates. The diagnosis of posterior uveitis requires the presence of infiltrative retinal lesions involving the posterior pole of the eye, usually with vitritis and often times with cystoid macular edema. The amount of cystoid macular edema will be graded by a standard protocol using Fluorescein Angiogram. The diagnosis of pan-uveitis requires the finding of active anterior segment inflammation, vitritis, and infiltrative retinal lesions.
• EXCLUSION CRITERIA:
• • Ocular or systemic disease requiring greater than 1 mg/kg/day of prednisone or greater than 80 mg qd if patients weigh more than 80 kg, or requiring other systemic immunosuppressants.
• • Periocular injections of corticosteroids within the previous 4 weeks.
• • Intolerance or contraindications to corticosteroids.
• • Female who is pregnant or lactating.
• • Patient refuses to use contraception during the study and 24 months after termination of active study therapy or undergo a cholestyramine washout regimen or an activated charcoal regimen under the care of a physician following termination of study therapy, if child-bearing or fathering potential exists.
• • Patients with Behcet's disease.
• • Use of Latanoprost within 2 weeks prior to enrollment, or current or likely need for Latanoprost during the course of the study.
• • Hypersensitivity to fluorescein dye.
• • Contraindications to use of steroids at dose and schedule.
• • SGOT (AST) or SGPT(ALT) greater than or equal to 2 times the upper limit of normal.
• • Allergic or hypersensitivity to leflunomide or any excipients.