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Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01892943
First Posted: July 8, 2013
Last Update Posted: May 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European Vision Institute Clinical Research Network
Information provided by (Responsible Party):
Santhera Pharmaceuticals
  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) ]
    The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF).


Enrollment: 306
Study Start Date: August 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with LHON

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892943


Locations
Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Denmark
Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology
Glostrup, Denmark, 2600
France
CHU Bordeaux
Bordeaux, France, 33000
CIC/CMR CHNO des Quinze-Vingts
Paris, France, 75012
Italy
Universty of Bari
Bari, Italy, 70100
Fondazione G.B. Bietti
Rome, Italy, 000199
San Raffaele Hospital
Segrate, Italy, 20132
Slovenia
University Eye Clinic
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Santhera Pharmaceuticals
European Vision Institute Clinical Research Network
Investigators
Principal Investigator: Jose-Alain Sahel, MD Centre de Recherche Institut de la Vision INSERMN
  More Information

Responsible Party: Santhera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01892943     History of Changes
Other Study ID Numbers: LHON HCR
First Submitted: June 26, 2013
First Posted: July 8, 2013
Last Update Posted: May 15, 2014
Last Verified: May 2014

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