Status:
COMPLETED
Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-infectious Intermediate Uveitis
Non-infectious Posterior Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 immunosuppre...
Detailed Description
Approximately 24 patients with active non-infectious uveitis, in at least one eye, requiring intensification of systemic immunosuppressive therapy were enrolled and randomized to receive intravitreal ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01526889
Start Date
December 20 2012
End Date
August 24 2017
Last Update
January 5 2021
Active Locations (8)
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1
Novartis Investigative Site
Golden, Colorado, United States, 80401
2
Novartis Investigative Site
Marietta, Georgia, United States, 30060
3
Novartis Investigative Site
Cambridge, Massachusetts, United States, 02142
4
Novartis Investigative Site
Omaha, Nebraska, United States, 68198-5540