Study of FTY720 in Patients With Uveitis

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

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

Study Overview

• Status: Withdrawn
• Conditions: Acute Noninfectious Posterior, Intermediate, or Pan Uveitis
• Intervention / Treatment: Drug: FTY720; Drug: Oral Corticosteroid

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FTY720; Fingolimod	Drug: FTY720; Fingolimod
Active Comparator: Oral Corticosteroid	Drug: Oral Corticosteroid; Oral Corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vitreous Haze Score in the Study Eye at Day 8	On day 8 of the study, the vitreous haze score will be measured in patients during a dilated fundus examination (using eye drops to enlarge the pupil of the eye). The ophthalmologist will examine the back of the eye to obtain this measure.	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vitreous Haze Score in the Study Eye on Study Examination Days	On study examination days, the vitreous haze score will be measured in patients during a dilated fundus examination (using eye drops to enlarge the pupil of the eye). The ophthalmologist will examine the back of the eye to obtain this measure.	Days 2, 4, 29, 57
Changes in Visual Acuity (Number of letters) in the Right and Left Eyes on Study Examination Days	Change in visual acuity will be assessed in the right and left eyes using the ETDRS (early treatment diabetic retinopathy study) visual acuity charts. Change in acuity is defined as the change in the number of letters correctly read on each chart.	Days 2, 4, 8, 29 and 57
Changes in Macular Thickness (Thickness at the Center of the Retina) in the Right and Left Eyes on Study Examination Days	Macular thickness will be measured using an OCT (optical coherence tomography or type of ultrasound of the eye) on the right and left eyes. This test measures how thick the retina is; the study measure is the thickness at the central part of the eye.	Days 2, 4, 8, 29 and 57
Measures of the Safety and Tolerability of the Study Medication FTY720; Also Measures of Whether the Patients Required Rescue Medication for their Uveitis.	This will be determined by how safe the study medication FTY720 is determined to be, by how well tolerated it is by the patients and also by whether the patients needed rescue medication (e.g. other medication to treat their uveitis if the study drug was not effective during the time they received it).	Days 2, 4, 8, 29 and 57
Levels of FTY720 and FTY720-P Blood Concentrations Measured in the Patients on Study Examination Days	The blood FTY720 and FTY720-P concentrations will be measured by collection of 3 mL of blood taken from the patients during specified study examination visits.	Days 2, 29 and 57

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Panuveitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720D2205; 2011-004160-30 (EudraCT Number)