Daclizumab Injections to Treat Non-Infectious Sight-Threatening Uveitis

INCLUSION CRITERIA: Participant is 6 or more years of age (there is no upper age limit). Participant has a diagnosis of non-infectious intermediate or posterior uveitis of at least three months duration prior to enrollment, requiring treatment during that period to control their intraocular inflammatory disease and avoid sight-threatening complications due to inflammation, with a prescribed dose averaging at least 20 mg/day (or greater then or equal to 0.25 mg/kg/day) of systemic prednisone (or equivalent) or any combination of two or more anti-inflammatory treatments for uveitis, or a regimen that includes one of the following or related compounds: cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil, or methotrexate. Participants are anticipated to have, but are not restricted to the following conditions known to cause intermediate or posterior uveitis: intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, birdshot retinochoroidopathy, retinal vasculitis and sympathetic ophthalmia. Participant's uveitis is considered stable on current medications at the time of enrollment. The prescribed dosage(s) for the current medications at enrollment must not have been increased in the 6 weeks prior to enrollment, and there are no symptoms or history of 'attacks' or exacerbation of intraocular inflammation during that 6 week period. Participant has uveitis with no worse than a grade of 1+ for anterior chamber cells or vitreous haze at enrollment. Participant has best-corrected distance visual acuity in at least one eye of 20/400 or better (ETDRS logMAR less than 1.34). Participant agrees not to undergo elective ocular surgery (e.g., cataract extraction) for the first 26 weeks of the study. Participant is not currently pregnant or lactating. Participant with reproductive potential and who is sexually active agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of the protocol treatment period. (Acceptable methods must be discussed by the participant with the Investigator, and may include use of condoms, diaphragms, IUDs, progesterone implants or injections, or double barrier methods.) Participant, or their parent or guardian if younger than 18 years at enrollment, is able to understand and sign an approved consent form before entering into the study; any minor participant must also sign an assent if required by the local Institutional Review Board or Independent Ethics Committee (IRB/IEC). EXCLUSION CRITERIA: Participants under the age of 6 years. Participants who have received previous treatment with an IL-2 directed monoclonal antibody. Participants who are currently enrolled in another clinical trial or who are using a therapy for a non-uveitis condition that would likely affect immune responses or interfere with trial logistics, or who have received any investigational therapy within the 30 days prior to enrollment. Participants with a history or diagnosis of Behcet's disease (since tapering or withdrawal of concomitant immunosuppressive medications is not a standard of care for Behcet's patients) or a primary diagnosis of anterior uveitis (e.g., juvenile rheumatoid arthritis (JRA) or HLA-B27 associated uveitis, ocular conditions usually treated with local and not systemic medications). Participants with a significant, systemic infection requiring medical treatment at the time of enrollment. Participants with a history of cancer (other than a non-melanoma skin cancer or in situ cervical cancer) diagnosed within the past 5 years. Participants with non-ocular, medically significant co-morbid conditions that impair normal activities, require immunosuppression, or who have a condition with a prognosis that indicates a significant risk of disability or death if the condition were to continue or be exacerbated during the study period, or a medical condition that would likely have an impact on the participant's ability to comply with the visit schedule. Such conditions may include, for example, recent heart attack, significant COPD, brittle diabetes, kidney disease, severe emphysema, organ transplant (requiring corticosteroids or other immunosuppressive medications), hepatitis or other liver disease, or uncontrolled psychiatric illnesses.