Table S1.
Inclusion criteria | |
---|---|
| |
1. ≥18 years of age | |
2. Having diagnosis of uveitis determined by the investigator to be noninfectious based on the patient’s medical history, history of present illness, ocular examination, review of systems, physical examination, and any relevant, pertinent laboratory evaluations | |
3. Patients with active uveitis, defined as having at least 1+ VH and/or at least 1+ vitreous cell count (SUN scale), and | |
4. are receiving no other treatment; or | |
5. are receiving prednisone ≥10 mg/day and/or at least one other systemic immunosuppressants | |
6. Patients with inactive disease, defined as having 0.5+ VH or less and a grade of 0.5+ vitreous cell count or less (SUN scale), and are receiving prednisone <10 mg/day and/or at least one other systemic immunosuppressants | |
7. Having posterior uveitis, intermediate uveitis, or panuveitis; for panuveitis, if an anterior component is present, it must be less than the posterior component | |
8. Sufficient inflammation to require systemic treatment | |
9. BCVA of 20/400 or better in both eyes | |
| |
Exclusion criteria | |
| |
Non-ocular | Ocular |
| |
1. Allergy or hypersensitivity to sirolimus or fluorescein dye 2. Immunosuppressive therapy within 30 days of day 0 3. Patients who are receiving strong inducers of CYP3A4 and P-gp and have any recent infection within 30 days of baseline 4. Immunocompromised patients 5. History of CMV infection or clinical evidence of active CMV infection at baseline 6. Malignancy in remission for <5 years prior to study 7. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of an investigational drug might affect the interpretation of the results of the study or renders the patient at high risk for treatment complications 8. Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions 9. Sexually active males with partners of child-bearing potential who are not using adequate contraceptive precautions |
1. Patients with bilateral uveitis who are receiving systemic IMT for the treatment of the fellow eye and cannot be controlled with standard local therapies alone 2. Any significant ocular disease that could compromise vision in the study eye 3. Any IVT injections or posterior subtenon’s steroids within 90 days prior to day 0 4. Intraocular surgery within 90 days prior to day 0 5. Capsulotomy within 30 days prior to day 0 6. History of vitreoretinal surgery or scleral buckling within 90 days prior to day 0 7. Any ocular surgery anticipated within the first 180 days following day 0 8. IOP ≥25 mmHg (glaucoma patients maintained on no more than two topical medications with IOP <25 mmHg are allowed) 9. Pupillary dilation inadequate for quality stereoscopic fundus photography 10. Media opacity that would limit clinical visualization, IVFA, or OCT evaluation 11. Presence of any form of ocular malignancy History of herpetic infection in the study eye or adnexa 12. Presence of known active or inactive toxoplasmosis in either eye 13. Ocular or periocular infection in either eye |
Abbreviations: BCVA, best-corrected visual acuity; CMV, cytomegalovirus; IMT, immunomodulatory therapy; IVFA, intravenous fluorescein angiography; IVT, intravitreal; OCT, optical coherence tomography; SUN, Standardization of Uveitis Nomenclature; VH, vitreous haze.