HAT in Eye Complications of Behcet's Disease

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

Keywords

ClinConnect Summary

The development of an ideal therapy to immunosuppress patients with Behcet's disease, a cause of endogenous uveitis and a major cause of acquired blindness in adults, is an important research goal. Corticosteroids remain the mainstay of therapy for intraocular inflammation; however, many patients are intolerant or resistant to corticosteroid therapy. Although the etiology of Behcet's disease is unknown, evidence suggests that an interleukin-2 receptor bearing auto-aggressive cells may play an important role in this disorder. Zenapax, a humanized anti-TAC (T-cell activated antigen) monoclona...

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • Patients must be 18 years of age or older for the primary randomized cohort.
• • Up to six additional patients under 18 but more than 6 years of age may enroll in a separate stratum.
• • Patients has ocular complications of Behcet's disease.
• • Patients is currently taking a minimum of 15 mg of prednisone, or cyclosporine, or anti-metabolites, or any combination of these for the treatment of their intraocular inflammatory disease and retinal vasculitis for at least the past 3 months.
• • Patients must have had at least two documented ocular attacks due to their Behcet's disease involving the posterior segment.
• • Patients has normal renal or liver function or evidence of only mild abnormalities as defined by the WHO criteria.
• • Patients has a neutrophil count above 750.
• • Patients agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of treatment if assigned to Zenapax. If patient is assigned to placebo and has been unmasked, the patient need not practice birth control.
• • Patients is able to understand and sign a consent form before entering into the study. Minor patients will be required to sign an assent.
• EXCLUSION CRITERIA:
• • Patients has received previous treatment with an IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy, or pharmacokinetics of Zenapax.
• • Patients has significant active infection.
• • Patients has a history of cancer (other than non-melanoma skin cancer) within the past 5 years.
• • Patient is pregnant or lactating.
• • Patients with significant symptomatic neurological disease which complicates evaluation of neurological sequelae of Behcet's disease. This would include multiple sclerosis, stroke, and other neurodegenerative disease are not eligible. Neuro-Behcet's disease would be permitted.
• • In the opinion of the treating physicians the ocular disease is end-stage, and there would be no reasonable hope for an improvement in visual acuity.
• • Patient has used Latanoprost within two weeks prior to enrollment, or has a current or likely need for Latanaprost during the course of the study.