Suspended

A Multicenter, Randomized, Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of FTY720 in Patients With Acute, Noninfectious Intermediate, Posterior and Pan Uveitis

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What is being tested

FTY720

+ Oral Corticosteroid

Drug
Who is being recruted

Amino Acid Metabolism, Inborn Errors+14

+ Brain Diseases

+ Brain Diseases, Metabolic

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2013
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: April 20, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2013

Actual date on which the first participant was enrolled.

This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis

NCT01791192
Principal SponsorNovartis Pharmaceuticals
Last updated: April 20, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 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

Amino Acid Metabolism, Inborn ErrorsBrain DiseasesBrain Diseases, MetabolicCentral Nervous System DiseasesEye DiseasesMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNutritional and Metabolic DiseasesUveal DiseasesBrain Diseases, Metabolic, InbornGenetic Diseases, InbornGenetic Diseases, X-LinkedUrea Cycle Disorders, InbornUveitisOrnithine Carbamoyltransferase Deficiency Disease

Criteria

Inclusion Criteria: Acute noninfectious posterior, intermediate, or pan uveitis Vitreous haze score of 1+ or more in the study eye at screening and baseline visits Exclusion Criteria: Vaso-occlusive vasculitis involving the retinal macula Behçet's uveitis Patients requiring corticosteroid or another systemic immunosuppressive medication for any other disease (e.g., asthma or some other autoimmune disease) that would contraindicate tapering (topical steroids permitted) Other protocol defined inclusions and/or exclusions may apply.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Fingolimod

Group II

Active Comparator
Oral Corticosteroid

Study Objectives

Primary Objectives

Secondary 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 no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers