E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Uveitis, intermediate; uveitis, posterior; uveitis, pan. |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation of the back of the eye |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10046851 |
E.1.2 | Term | Uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of FTY720 on vitreous haze at Day 8 in patients with acute noninfectious posterior, intermediate, or pan uveitis |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of FTY720 on vitreous haze at Days 2, 4, 29 and 57 in patients with acute noninfectious posterior, intermediate, or pan uveitis
To assess the effect of FTY720 on Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity at Days 2, 4, 8, 29 and 57 in acute noninfectious posterior, intermediate, or pan uveitis
To assess the effect of FTY720 on central sub-field macular thickness at Days 2, 4, 8, 29 and 57 in acute noninfectious posterior, intermediate, or pan uveitis
To assess the effect of FTY720 on need for rescue medication in patients with acute noninfectious posterior, intermediate, or pan uveitis
To assess the safety and tolerability of FTY720 in patients with acute noninfectious posterior, intermediate, or pan uveitis
To measure the blood FTY720 and FTY720-P concentrations in patients with acute noninfectious posterior, intermediate, or pan uveitis
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written informed consent must be obtained before any assessment is performed.
• Male and female subjects, age 18 to 60 years of age with active posterior, intermediate, or pan uvetis.
• Vitreous haze score of 1+ or more in the study eye at screening and baseline visit. |
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E.4 | Principal exclusion criteria |
Exclusions:
1. Vaso-occlusive vasculitis involving the retinal macula
2. Behçet’s uveitis
3. A history of clinically significant macular edema in either eye within 8 weeks of the screening visit
4. Evidence of retinal or sub-retinal fluid on OCT consistent with macular edema of sufficient severity to reduce visual acuity.
5. A clinical history of multiple sclerosis (MS)
6. Patients receiving Class Ia or Class III antiarrhythmic drugs, beta blockers, calcium channel blockers; those with a low heart rate (HR), history of syncope, sick sinus syndrome, 2nd degree or higher conduction block, ischemic heart disease, or congestive heart failure
7. 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)
8. Patients with a negative varicella zoster antibody titer
9. Patients who have been treated with > 20mg prednisone on any day within 3 weeks prior to screening
10. Patients with known, active malignancies, except for patients with cutaneous basal cell carcinoma |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. ETDRS visual acuity, central sub-field macular thickness
2. need for rescue medication |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |