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This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®.
No medication will be provided as part of this study. Raxone® will be obtained through commercial channels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who are treated with Raxone® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idebenone | Drug | Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care. | Safety will be assessed by the collection and analysis of adverse events of special interest (AESIs), frequency and nature of AEs and serious adverse events (SAEs), adverse drug reactions (ADRs) and serious adverse drug reactions (SADRs) | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care | According to the Summary of Product Characteristics (SmPC) a patient's vision should be continually monitored therefore effectiveness will be assessed by measuring on-therapy changes in patients' visual acuity (VA), visual fields (VF), colour contrast sensitivity and Retinal Nerve Fibre Layer thickness (RNFL) where available. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient prescribed Raxone® for the treatment of LHON who have completed the informed consent. This study will be conducted in EU in approximately 45 highly specialized centres in ophthalmology and neuroophthalmology.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Graz | Graz | 8036 | Austria | |||
| Medical University of Vienna |
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| up to 5 years |
| Vienna |
| Austria |
| CHU de Nîmes - Hôpital Carémeau | Nîmes | Gard | 30029 | France |
| CHU Angers - Hôpital Hôtel Dieu | Angers | Maine Et Loire | 49033 | France |
| Hopital Roger Salengro - CHU Lille | Lille | Nord | 59037 | France |
| Hôpital Européen Georges Pompidou | Paris | Paris Cedex 15 | 75908 | France |
| CHU Amiens - Centre Saint Victor | Amiens | Somme | 80054 | France |
| Hospices Civils de Lyon | Lyon | 69002 | France |
| Hopital Neurologique Pierre Wertheimer | Lyon | 69677 | France |
| Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts | Paris | 75012 | France |
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
| Julius Maximilians University | Würzburg | Bavaria | 97070 | Germany |
| Universitaetsklinikum Essen | Essen | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | Germany |
| Friedrich-Baur-Institut | Munich | Germany |
| Universitaetsklinikum Muenster | Münster | Germany |
| Dietrich-Bonhoeffer-Klinikum Neubrandenburg | Neubrandenburg | Germany |
| Universitaetsklinikum Regensburg | Regensburg | Germany |
| Athens Ophthalmological Center | Athens | 11528 | Greece |
| Università di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche | Bologna | 40123 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliera S. Camillo Forlanini | Rome | 00152 | Italy |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Maastricht University Medical Center | Maastricht | 6211 LK | Netherlands |
| ID | Term |
|---|---|
| D029242 | Optic Atrophy, Hereditary, Leber |
| ID | Term |
|---|---|
| D015418 | Optic Atrophies, Hereditary |
| D009896 | Optic Atrophy |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C036619 | idebenone |
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