Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)
NCT ID: NCT02796274
Last Updated: 2020-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
219 participants
OBSERVATIONAL
2016-05-31
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. the onset of symptoms is dated after 1999 and is well documented (at least month of onset of symptoms is known for each eye)
3. at least two VA assessments are available within 5 years of onset of symptoms and prior to idebenone use
4. have a genetic diagnosis for LHON for one of the following mitochondrial DNA (mtDNA) mutations: G11778A, G3460A, T14484C
Exclusion Criteria
2. any other cause of visual impairment (e.g. glaucoma, diabetic retinopathy, AIDS related visual impairment, cataract, macular degeneration, etc.) or any active ocular disorder (uveitis, infections, inflammatory retinal disease, thyroid eye disease, etc.) during the data collection period
12 Years
ALL
No
Sponsors
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Santhera Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Klopstock, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Friedrich-Baur-Institut, Muenchen, Germany
Locations
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CHU Saint-Pierre
Brussels, , Belgium
Cliniques Universitaire Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
C. H. U. Sart Tilman
Liège, , Belgium
CHU Angers - Hôpital Hôtel Dieu
Angers, , France
Hopital Roger Salengro - CHU Lille
Lille, , France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
CHU Reims - Hôpital Robert Debré
Reims, , France
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, , France
Justus-Liebig-Universitaet Giessen
Giessen, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Friedrich-Baur-Institut
München, , Germany
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Università di Pisa
Pisa, , Italy
G. B. Bietti Fondazione - IRCCS
Rome, , Italy
Maastricht University Medical Center
Maastricht, , Netherlands
Oogziekenhuis Rotterdam
Rotterdam, , Netherlands
Haukeland Universitetssykehus
Bergen, , Norway
University Hospital of Wales
Cardiff, , United Kingdom
Queen's Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SNT-CRS-002
Identifier Type: -
Identifier Source: org_study_id
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