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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004160-30 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTY720 | Experimental | Fingolimod |
|
| Oral Corticosteroid | Active Comparator | Oral Corticosteroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTY720 | Drug | Fingolimod |
| |
| Oral Corticosteroid |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D020163 | Ornithine Carbamoyltransferase Deficiency Disease |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D056806 | Urea Cycle Disorders, Inborn |
| D020739 | Brain Diseases, Metabolic, Inborn |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
Oral Corticosteroid |
|
| 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 |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |