Clinical Trial: Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,

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 Panuve

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

Detailed Summary:

Approximately 24 patients with active non-infectious uveitis, in at least one eye, requiring intensification of systemic immunosuppressive therapy will be enrolled and randomized to receive intravitreal LFG316 or conventional therapy (investigator's discretion). Only one eye (the study eye) will be treated with LFG316 and the other eye (fellow eye) will be treated at the investigator's discretion.Throughout the study, the fellow eye may be treated as needed; except that certain systemic medications are prohibited There will be 1 screening and 8 scheduled visits over 85 days for a total of 9 site visits for all patients.

At Day 85, patients receiving LFG316 treatment who meet the criteria for a 'responder', will be offered an additional 6 months of LFG316 treatment on a PRN basis. Additional 3 scheduled visits will be attended by LFG316-responder patients during the extension period. However, patients can have unscheduled visits as needed and as determined by the investigator. Safety evaluation and ocular assessments will be performed throughout the study duration.

Patients in the treatment extension phase, who experience a flare post their last dose and require treatment, may receive a dose of LFG316. These patients will be assessed for a response at their next PRN visit as scheduled by the investigator. Visit frequency is determined by the investigator. If they continue to respond to LFG316 therapy, they may remain in the PRN treatment arm. They may receive up to 7 additional doses of LFG316 in the PRN period. Throughout the trial LFG316 will not be administered more frequently than monthly.

Patients in the extension phase, who discontinue treatment prematurely will be asked to return approximately 1 month after their last dose.

Vitreous haze will be assessed in masked manner to evaluate the clinical activity of LFG316