Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis
The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg) adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration, given at zero, 2 weeks then every four weeks, in subjects with active non-infectious intermediate-, posterior-, or pan-uveitis.
• Subject is ≥ 18 years of age.
• Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.
• Subject must have active disease at baseline as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of prednisone ≥ 10 mg/day (or oral corticosteroid equivalent):
‣ Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
⁃ ≥ 1+ anterior chamber cells (Standardization of Uveitis Nomenclature \[SUN\] criteria)
⁃ ≥ 1+ vitreous haze (National Eye Institute \[NEI\]/SUN criteria)
• Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day).
• If subject is on prednisone \>=10 mg (or corticosteroid equivalent) at baseline, the dose has not been increased or decreased in the past 14 days.
• No increase in the immune modulatory therapy in the past three months
• Negative PPD test.
• Positive PPD test on anti Tb medications.