EYEGUARD™-AA 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
Placebo
+ Dose 1 gevokizumab
+ Dose 2 gevokizumab
Eye Diseases+3
+ Uveal Diseases
+ Uveitis
Treatment Study
Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 116 locations