Protocol Number: 02-EI-0242

Title:

Evaluation of Subcutaneous Daclizumab Treatments in Patients with Non-infectious Sight-threatening Uveitis: A Multicenter, Open-Label, Phase II Study

Number:

02-EI-0242

Summary:

This study will examine the safety and effectiveness of a monoclonal antibody called daclizumab in treating uveitis, an eye inflammation. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. Daclizumab is designed to prevent a specific chemical interaction needed for immune cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10 adults with uveitis, 8 patients were able to decrease corticosteroids and other immunosuppressive medicines they were taking while receiving daclizumab for months or even years. The study will be conducted at three different sites, including the NIH Clinical Center.

Patients 6 years of age and older with non-infectious uveitis of at least 3 months' duration who require treatment with immune suppressing medicines, such as prednisone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, or others, may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, complete eye examination, and a questionnaire about the patient's vision and daily activities.

Participants will come to the study center every 2 weeks for treatment and evaluation. Daclizumab treatments are given by injection under the skin, usually in the arm. Patients will receive a maximum of 28 treatments over a 1-year period. Treatment may be extended for a few months while other participants reach their 1-year mark. The first two induction treatments are at a higher dose (2 mg/kg of body weight) than the maintenance dose of 1 mg/kg. After the first daclizumab treatment, other uveitis medications will be tapered, one at a time. If the disease remains quiet, these drugs may eventually be stopped completely.

For the first 6 months, all patients will receive daclizumab injections and evaluations every 2 weeks. After that, if other medications have been reduced and vision has remained stable, treatments and evaluations may be spread out to every 3 or 4 weeks. Over time, fewer tests may be required during the biweekly examinations if the patient is doing well, but nearly all the examinations done at screening will be repeated at 3-month intervals. If inflammation or vision loss occurs during drug tapering, appropriate treatment will be administered. If the vision loss is too great, the patient will be treated with steroids or other medicines and taken off the study.

Additional, special tests done at selected study centers include the following:

-Fluorescein angiography: This test is done to check for abnormalities of eye blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken with a special camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible abnormalities.

-Pelvic ultrasound and urine test: These tests are done at enrollment and after 1 year to check the kidneys, lymph nodes, and pelvic area.

-Blood tests: Additional blood tests are done at enrollment and every 3 to 6 months for laboratory and immunology study.

Sponsoring Institute:

National Eye Institute (NEI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Interleukin 2

IL-2 Receptor

Anti-CD25

Anti-Tac

Anti-IL-2R

Uveitis

Daclizumab

Recruitment Keywords:

Uveitis

Inflammatory Eye DIsease

Conditions:

Uveitis

Investigational Drug(s):

Daclizumab

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Caspi RR, Roberge FG, McAllister CG, el-Saied M, Kuwabara T, Gery I, HannaE, Nussenblatt RB T cell lines mediating experimental autoimmune uveoretinitis (EAU) in the ratJ Immunol 1986 Feb 1;136(3):928-33PMID: 2416842

Lacomba MS, Martin CM, Chamond RR, Galera JM, Omar M, Estevez EC Aqueous and serum interferon gamma, interleukin (IL) 2, IL-4, and IL-10 inpatients with uveitisArch Ophthalmol 2000 Jun;118(6):768-72PMID: 10865312

Reed MH, Shapiro ME, Strom TB. Prolongation of primate renal allograft survival by anti-Tac, an anti-human IL-2 receptor monoclonal antibody.Transplantation. 1989 Jan;47(1):55-9.

PMID: 2643232

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Warren Grant Magnuson Clinical Center (CC)
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Bethesda, Maryland 20892. Last update: 10/21/2004