Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

This study is not yet open for participant recruitment.
Verified July 2013 by Santhera Pharmaceuticals
Sponsor:
Collaborator:
European Vision Clinical Research (EVICR) Network
Information provided by (Responsible Party):
Santhera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01892943
First received: June 26, 2013
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition
Leber Hereditary Optic Neuropathy (LHON)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Santhera Pharmaceuticals:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: average 0 to 10 years (retrospective) ] [ Designated as safety issue: No ]
    The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF).


Estimated Enrollment: 350
Study Start Date: August 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with LHON

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with genetically confirmed diagnosis of LHON

Criteria

Inclusion Criteria:

  • patients with genetically confirmed diagnosis of LHON
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01892943

Locations
Belgium
University Hospitals Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Werner Spillers, Prof Dr         
Principal Investigator: Werner Spillers, Prof Dr         
France
Centre de Recherche Institut de la Vision INSERMN U 968 Not yet recruiting
Paris, France, 75012
Contact: Jose-Alain Sahel, Prof         
Principal Investigator: Jose-Alain Sahel, Prof         
Sponsors and Collaborators
Santhera Pharmaceuticals
European Vision Clinical Research (EVICR) Network
  More Information

No publications provided

Responsible Party: Santhera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01892943     History of Changes
Other Study ID Numbers: LHON HCR
Study First Received: June 26, 2013
Last Updated: July 8, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Optic Atrophy, Hereditary, Leber
Optic Atrophies, Hereditary
Eye Diseases, Hereditary
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014