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Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment (EYEGUARD™-C)

This study has been terminated.
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
XOMA (US) LLC Identifier:
First received: December 7, 2012
Last updated: July 11, 2016
Last verified: July 2016
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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 Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Proportion of subjects with an occurrence of uveitic disease through Day 168 [ Time Frame: Day 0 through Day 168 ]

Secondary Outcome Measures:
  • Time to first occurrence of uveitic disease [ Time Frame: Day 0 through Day 168 ]

Enrollment: 281
Study Start Date: October 2012
Primary Completion Date: June 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
  • Controlled uveitic disease in both eyes
  • Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
  • Effective contraceptive measures

Exclusion Criteria:

  • Infectious uveitis and masquerade syndromes
  • Isolated anterior uveitis
  • Contraindication to mydriatics
  • Active tuberculosis disease
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • 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: NCT01747538

  Show 115 Study Locations
Sponsors and Collaborators
Institut de Recherches Internationales Servier
  More Information

Responsible Party: XOMA (US) LLC Identifier: NCT01747538     History of Changes
Other Study ID Numbers: X052131/CL3-78989-006
2012-001609-25 ( EudraCT Number )
U1111-1135-1462 ( Other Identifier: WHO )
Study First Received: December 7, 2012
Last Updated: July 11, 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 September 18, 2017