Study of FTY720 in Patients With Uveitis

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

Official Title
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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

Conditions
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Acute Noninfectious Posterior, Intermediate, or Pan Uveitis

Intervention / Treatment
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* Drug: FTY720
* Drug: Oral Corticosteroid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FTY720<br>Fingolimod | Drug: FTY720<br>* Fingolimod<br>|
| Active Comparator: Oral Corticosteroid<br>Oral Corticosteroid | Drug: Oral Corticosteroid<br>* Oral Corticosteroid<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT