Leflunomide to Treat Uveitis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00001863
• Date of registration: 03/11/1999
• Primary sponsor: National Eye Institute (NEI)
• Public title: Leflunomide to Treat Uveitis
• Scientific title: Pilot Study of Leflunomide for the Treatment of Uveitis
• Date of first enrolment: March 1999
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001863
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Uveitis

Intervention(s)

Drug: Leflunomide

Secondary ID(s)

99-EI-0059

990059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors