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: October 14, 2015
Last verified: October 2015
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    A response is defined as an improvement of the study eye without deterioration in the contralateral eye.

Enrollment: 200
Study Start Date: August 2012
Estimated 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01684345

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Sponsors and Collaborators
Institut de Recherches Internationales Servier
  More Information

No publications provided

Responsible Party: XOMA (US) LLC Identifier: NCT01684345     History of Changes
Other Study ID Numbers: X052130/CL3-78989-005, 2012-001610-42
Study First Received: September 10, 2012
Last Updated: October 14, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Eye Diseases
Uveal Diseases processed this record on November 27, 2015