Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Noninfectious Uveitis

In brief

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).

Key facts

Study ID

NCT01243983

Run by

Lux Biosciences, Inc.

People needed

155

Starts

2011-02-01

Expected to finish

2012-12-01

Last updated by the study team

2013-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Mountain View, California, United States
• Study site — Sacramento, California, United States
• Study site — Santa Ana, California, United States
• Study site — Torrance, California, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Ellsworth, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Cambridge, Massachusetts, United States
• Study site — Newark, New Jersey, United States
• Study site — Belmont, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Dublin, Ohio, United States
• Study site — Middleburg Heights, Ohio, United States
• Study site — Ashland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Ladson, South Carolina, United States
• Study site — Arlington, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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