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

• Status: Completed
• Trial end date: 2017-08-24
• Target enrollment: 0
• Participant gender: All

Summary

This was a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy were enrolled.

Safety, efficacy, and PK assessments occurred at scheduled visits over a 12-week period. Low-molecular-weight non-steroidal immunosuppressive medications were allowed up to the baseline day as long as the dose had not changed in the 3 weeks prior to baseline, except for corticosteroid doses for which might have changed.

Patients responding to treatment were offered up to 6 months of extended treatment. Assessments for safety included laboratory safety tests, ECGs, physical exams, ocular exams, vital signs and the monitoring of adverse events. Study participation varied from a minimum of 3 months to a maximum of 9 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Male or female patients 18 years or older

• Active NIU, in at least one eye, as defined below, in patients requiring intensification of systemic immunosuppressive therapy;

• Vitreous haze at least 1+ on the scale of Nussenblatt et al 1985,or

• Chorioretinal lesions due to uveitis (chorioretinal lesions due to infectious uveitis excluded)

• Patients with a flare and at the time of the enrollment on systemic corticosteroid or non-steroidal immunosuppressants had their therapy tapered or stopped, respectively, at the time of intravitreal LFG316 administration.

Visual acuity (ETDRS method) of 20 letters (20/400 Snellen equivalent) or better in the study eye.

• For female patients, must not be pregnant or lactating and must, unless post-menopausal, use effective contraception.

• Ability to provide informed consent and comply with the protocol.

Key Exclusion Criteria:

• Uveitis so severe that, in the investigator's judgment, it was too risky to test an experimental drug

• Any biologic immunosuppressive agent given via intravitreal, intravenous or subcutaneous route within 4-12 months depending on the agent.

• History of infectious uveitis or endophthalmitis in either eye.

• History of retinal detachment

• Any intraocular surgery, intravitreal injection, periocular injection, or laser photocoagulation to the study eye within 90 days prior to dosing.

• In the study eye, cataract expected to interfere with study conduct or require surgery during the study.

• Forms of uveitis that may have spontaneously resolved