CompletedPhase 3

Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

United States155 participantsStarted 2011-02

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

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.

Timeframe: 12 weeks

Trial details

NCT IDNCT01243983

SponsorLux Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Noninfectious Uveitis trials