Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

NCT ID: NCT01892943

Last Updated: 2014-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Leber Hereditary Optic Neuropathy (LHON)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with LHON

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients with genetically confirmed diagnosis of LHON
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Vision Institute Clinical Research Network

NETWORK

Sponsor Role collaborator

Santhera Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose-Alain Sahel, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche Institut de la Vision INSERMN

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology

Glostrup Municipality, , Denmark

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

CIC/CMR CHNO des Quinze-Vingts

Paris, , France

Site Status

Universty of Bari

Bari, , Italy

Site Status

Fondazione G.B. Bietti

Rome, , Italy

Site Status

San Raffaele Hospital

Segrate, , Italy

Site Status

University Eye Clinic

Ljubljana, , Slovenia

Site Status

Countries

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Belgium Denmark France Italy Slovenia

Other Identifiers

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LHON HCR

Identifier Type: -

Identifier Source: org_study_id

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