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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01892943
Other study ID # LHON HCR
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05293626 - Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND4 Mutations Phase 1/Phase 2
Recruiting NCT05820152 - Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND1 Mutations Phase 1/Phase 2