Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Active-controlled, Open-label, Multicenter proof-of Concept Study of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, Posterior-, or Panuveitis Requiring Systemi
Brief Summary:
This is a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy will be enrolled.
Safety, efficacy, and PK assessments will occur at scheduled visits over a 12-week period. Low-molecular-weight non-steroidal immunosuppressive medications are allowed up to the baseline day as long as the dose has not changed in the 3 weeks prior to baseline, except for corticosteroid doses for which may change.
Patients responding to treatment will be offered up to 6 months of extended tretment Assessments for safety will include laboratory safety tests, ECGs, physical exams, ocular exams, vital signs and the monitoring of adverse events.
Study participation may vary from a minimum of 3 months to a maximum of 9 months