Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lux Biosciences, Inc.

Criteria

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.