Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

Leber Hereditary Optic Neuropathy (LHON) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892943
• Other study ID #: LHON HCR
• Status: Completed
• Phase: N/A
• First received: June 26, 2013
• Last updated: May 14, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Santhera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leber Hereditary Optic Neuropathy (LHON)
• Optic Atrophy, Hereditary, Leber
• Optic Nerve Diseases

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Santhera Pharmaceuticals	European Vision Institute Clinical Research Network

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Italy,  Slovenia, 

Outcome

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