Clinical trial NCT01243983: Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis
Official title: A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Noninfectious Uveitis
Lead sponsor: Lux Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Daily mean systemic corticosteroid dose used during Weeks 12-24
timeFrame: Weeks 12-24
measure: Time to augmentation with corticosteroid therapy.
timeFrame: Week 24
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Indianapolis
country: United States
state: Indiana
city: Ellsworth
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Cambridge
country: United States
state: Massachusetts
city: Newark
country: United States
state: New Jersey
city: Belmont
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dublin
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Ashland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Ladson
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Vienna
country: Austria
city: Recife
country: Brazil
city: Rio de Janeiro
country: Brazil
city: São Paulo
country: Brazil
city: Ottawa
country: Canada
state: Ontario
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Prague
country: Czech Republic
city: Angers
country: France
city: Bordeaux
country: France
city: Paris
country: France
city: Paris
country: France
city: Münster
country: Germany
city: Tübingen
country: Germany
city: Bologna
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Parma
country: Italy
city: Reggio Emilia
country: Italy
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: York
country: United Kingdom
Study officials:
affiliation: Chief Medical Officer
name: Eddy Anglade, M.D.
role: STUDY_CHAIR
References: