Overview

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