Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis
- Registration Number
- NCT01243983
- Lead Sponsor
- Lux Biosciences, Inc.
- 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 the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
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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.
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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.
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Ocular Disease/Conditions
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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.
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Prior and Current Treatment:
- As defined in the protocol
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Extraocular Conditions:
- As defined in the protocol.
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Laboratory, Blood Pressure and ECG Evaluations:
- As defined in the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LX211 LX211 - Placebo LX211 -
- Primary Outcome Measures
Name Time Method The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier. 12 weeks
- Secondary Outcome Measures
Name Time Method Daily mean systemic corticosteroid dose used during Weeks 12-24 Weeks 12-24 Time to augmentation with corticosteroid therapy. Week 24