Status:
COMPLETED
Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis
Lead Sponsor:
Lux Biosciences, Inc.
Conditions:
Noninfectious Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of...
Eligibility Criteria
Inclusion
- Active noninfectious uveitis involving the intermediate and/or posterior segment (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified.
- Subjects must be:
- Capable of understanding the purpose and risks of the study.
- Able to give written informed consent.
- Able to comply with all study requirements.
Exclusion
- Ocular Disease/Conditions
- The following conditions are exclusionary if present:
- Uveitis limited to only the anterior segment of the study eye.
- Confirmed or suspected infectious uveitis in either eye.
- Prior and Current Treatment:
- \- As defined in the protocol
- Extraocular Conditions:
- \- As defined in the protocol.
- Laboratory, Blood Pressure and ECG Evaluations:
- As defined in the protocol.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT01243983
Start Date
February 1 2011
End Date
December 1 2012
Last Update
January 10 2013
Active Locations (52)
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1
Peoria, Arizona, United States, 85381
2
Phoenix, Arizona, United States, 85014
3
Little Rock, Arkansas, United States, 72205
4
Beverly Hills, California, United States, 90211