Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

May 14, 2014 updated by: Santhera Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven
  • Denmark
      • Glostrup, Denmark, 2600
        • Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology
  • France
      • Bordeaux, France, 33000
        • CHU Bordeaux
      • Paris, France, 75012
        • CIC/CMR CHNO des Quinze-Vingts
  • Italy
      • Bari, Italy, 70100
        • Universty of Bari
      • Rome, Italy, 000199
        • Fondazione G.B. Bietti
      • Segrate, Italy, 20132
        • San Raffaele Hospital
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with genetically confirmed diagnosis of LHON

Description

Inclusion Criteria:

  • patients with genetically confirmed diagnosis of LHON

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients with LHON

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
average 0 to 10 years (retrospective)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santhera Pharmaceuticals

Collaborators

European Vision Institute Clinical Research Network

Investigators

  • Principal Investigator: Jose-Alain Sahel, MD, Centre de Recherche Institut de la Vision INSERMN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (Estimate)

July 8, 2013

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LHON HCR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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