Efficacy and safety of gevokizumab in the treatment of patients with active non-infectious uveitis currently controlled with systemic treatment

• Conditions: on-infectious Intermediate, Posterior, or Pan- Uveitis.; MedDRA version: 14.1Level: PTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10042745Term: Sympathetic uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10012692Term: Diabetic uveitisSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-001609-25-IT
• Lead Sponsor: XOMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Diagnosis of non-infectious intermediate, posterior, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (SUN criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history; - Controlled uveitic disease in both eyes, defined by no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber cell grade < or = 0.5+ according to SUN criteria, Vitrous Haze grade < or = 0.5+ according to the SUN/NEI Scoring for Vitrous Haze; - Best Corrected Visual Acuity of 35 letters or more in both eyes; - Patients with a stable dose of oral corticosteroids, alone or in combination with selected stable immunosuppressive therapy; - Male or female, age =18 (or legal age of majority in the country) at selection; - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Infectious uveitis and masquerade syndromes ; - Isolated anterior uveitis; - Best corrected visual acuity < 35 letters in both eyes or monocular vision; - Presence of severe cataract or severe posterior capsular opacification; - Contraindication to mydriatics or presence of posterior synechiae, in either eye; - Active TB disease; - History of severe allergic or anaphylactic reactions to monoclonal antibodies; - History of malignancy within 5 years prior to Selection; - Infectious disease; - Known immunodeficiency; - Pregnancy, breastfeeding or possibility to become pregnant during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified