About this trial
FOCUS is the first prospective randomized study comparing standard of care (mycophenolate mofetil) to adalimumab in recently active non infectious uveitis (NIU) with steroid dependency. There is no firm evidence or randomized trials that compared classical immunosuppressive compounds to biological agents; or identified the best treatment in this condition. The burden of NIU has been reduced with the use of immunosuppressive agents and biologics, raising the question of which of these compounds should be preferentially used in recently active NIU with steroid dependency.
Eligibility criteria
Qualifiers
Provide written, informed consent prior to the performance of any study-specific procedures
≥18 years of age
Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of posterior, or pan- uveitis confirmed by documented medical history
Active chorioretinal or retinal vascular lesion
Disqualifiers
Infectious uveitis, masquerade syndromes (idiopathic uveitis is permitted)
Isolated anterior uveitis
Monocular patient
Active tuberculosis
Trial design
Treatments tested in this trial
- Adalimumab
- Mycophenolate Mofetil