Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
Condition: Non-infectious Intermediate Uveitis; Non-infectious Posterior Uveitis; Non-infectious Panuveitis
MeSH terms: Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis
Intervention: LFG316; Conventional Therapy
Intervention description: LFG316 administered intravitreally (IVT); Conventional Therapy administered in accordance with its prescribing info.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-infectious uveitis; Panuveitis; Visual acuity; Vitreous Haze; Inflammation of the uvea; inflammation of the middle, pigmented vascular structures of the eye, iris, ciliary body, choroid plexus

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.
    

Eligibility 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