INCLUSION CRITERIA:
Volunteers will be considered eligible participants for this study provided they meet all of the following inclusion criteria:
1. Participant has a diagnosis of active, non-infectious intermediate or posterior uveitis, which may include but is not restricted to the following conditions known to cause intermediate or posterior uveitis: panuveitis, intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, birdshot retinochoroidopathy, retinal vasculitis and sympathetic ophthalmia;
2. Participant has active uveitis with greater than or equal to Grade 1 (1+) vitreous haze in at least one eye including evidence of retinal vascular leakage using fluorescein angiography or the presence of cystoid macular edema (CME) at enrollment;
3. Participant's uveitis is currently treated or untreated at the time of enrollment;
4. Participant has best-corrected distance visual acuity (BCVA) in the worst eye of 20/400 or better (ETDRS logMAR less than 1.34);
5. Participant does not plan to undergo elective ocular surgery (e.g., cataract extraction) during the study period;
6. Participant, male or female, with reproductive potential and who is sexually active agrees to use double-barrier contraception methods throughout the course of the study (minimum of 52 weeks) and for 6 additional weeks after completion of the protocol treatment period.
EXCLUSION CRITERIA:
A volunteer will not be permitted to enroll if they meet any one of the following exclusion criteria:
1. Participant is under 18 years of age;
2. Participant has received previous treatment with an IL-2 or IL-2R directed therapy within the past 90 days;
3. Participant has lens opacities or obscured anterior ocular media upon enrollment such that reliable evaluation and grading of posterior segment cannot be performed (except that anterior chamber cells due to inflammation is not an exclusion);
4. Participant has a history of an active herpes zoster or varicella infection within 6 weeks before enrollment, or chicken pox exposure within 21 days before enrollment.
5. Participant has a known history of HIV infection;
6. Participant is currently enrolled in another investigational or interventional therapeutic trial, or is using a therapy for a non-uveitis condition that would likely affect immune responses or interfere with trial logistics, or has received any investigational therapy within the 30 days prior to enrollment;
7. Participant has a history or diagnosis of Behcet's disease (since subsequent 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., HLA-B27 associated uveitis, or ocular conditions usually treated with local and not systemic medications);
8. Participant has a significant local or systemic infection requiring medical treatment at the time of enrollment;
9. Participant is currently pregnant or lactating;
10. Participant has a history of cancer (other than a non-melanoma skin cancer or in situ cervical cancer) diagnosed within the past 5 years;
11. Participant has a non-ocular, medically significant co-morbid condition that impairs normal activities, requires immunosuppression, or has 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.
Warren Grant Magnuson Clinical Center (CC)