Leber Hereditary Optic Neuropathy (LHON) Clinical Trial
Verified date | May 2014 |
Source | Santhera Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Observational |
The objective of this survey is to establish the clinical course of vision loss and recovery
in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy
(LHON).
Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be
the main endpoint analysed.
The survey will collect historically documented visual acuity data for all patients at
participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria
apply. Patients are not required to attend the clinic for the survey.
Data will be collected in a completely anonymous manner. Ethical approvals and data release
agreements will be obtained as required by local regulations.
Status | Completed |
Enrollment | 306 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - patients with genetically confirmed diagnosis of LHON |
Observational Model: Case-Only, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven | |
Denmark | Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology | Glostrup | |
France | CHU Bordeaux | Bordeaux | |
France | CIC/CMR CHNO des Quinze-Vingts | Paris | |
Italy | Universty of Bari | Bari | |
Italy | Fondazione G.B. Bietti | Rome | |
Italy | San Raffaele Hospital | Segrate | |
Slovenia | University Eye Clinic | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
Santhera Pharmaceuticals | European Vision Institute Clinical Research Network |
Belgium, Denmark, France, Italy, Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual acuity | The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF). | average 0 to 10 years (retrospective) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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