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Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis (EYEGUARD™-A)

This study has been terminated.
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
XOMA (US) LLC Identifier:
First received: September 10, 2012
Last updated: April 7, 2016
Last verified: April 2016
The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

Condition Intervention Phase
Drug: Placebo
Drug: Dose 1 gevokizumab
Drug: Dose 2 gevokizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

Resource links provided by NLM:

Further study details as provided by XOMA (US) LLC:

Primary Outcome Measures:
  • The proportion of responders at Day 56 [ Time Frame: Day 56 ]
    A response is defined as an improvement of the study eye without deterioration in the contralateral eye.

Enrollment: 200
Study Start Date: August 2012
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Solution for subcutaneous injection
Experimental: Dose 1 gevokizumab Drug: Dose 1 gevokizumab
Solution for subcutaneous injection
Experimental: Dose 2 gevokizumab Drug: Dose 2 gevokizumab
Solution for subcutaneous injection


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
  • Active uveitic disease in at least one eye
  • Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
  • Effective contraceptive measures

Exclusion Criteria:

  • Infectious uveitis and masquerade syndromes
  • Isolated anterior uveitis
  • Contraindication to mydriatics
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • Active tuberculosis disease
  • History of recurrent infection or predisposition to infection; active ocular infection
  • Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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Please refer to this study by its identifier: NCT01684345

  Show 116 Study Locations
Sponsors and Collaborators
Institut de Recherches Internationales Servier
  More Information

Responsible Party: XOMA (US) LLC Identifier: NCT01684345     History of Changes
Other Study ID Numbers: X052130/CL3-78989-005
2012-001610-42 ( EudraCT Number )
Study First Received: September 10, 2012
Last Updated: April 7, 2016

Keywords provided by XOMA (US) LLC:
Non-infectious Uveitis
Intermediate Uveitis
Posterior Uveitis

Additional relevant MeSH terms:
Uveal Diseases
Eye Diseases processed this record on May 25, 2017