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REALITY LHON Registry | Clinical Trials | Clareo Health

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REALITY LHON Registry

Observational Registry Study of Leber Hereditary Optic Neuropathy (LHON) Affected Patients

NCT03295071•GenSight Biologics

Summary

This study is a multi-country retrospective and cross-sectional observational study of affected LHON subjects, based on retrospective subjects' medical chart abstractions and cross-sectional administration of patient-reported outcomes (PROs).

Detailed Description

The purpose of this study is to understand the evolution of visual functional and structural changes and other associated symptoms in patients with LHON. The relation between genetic, lifestyle and/or environmental factors and the LHON disease will be described, and a better understanding of the natural history of LHON disease and the healthcare associated to with the disease will be sought. In addition, we would also like to understand the economic burden for patients and their families with LHON resulting from direct and indirect costs they may have because of their disease.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects who have a confirmed and genotyped diagnosis of LHON;
•Subjects with visual function outcomes data including at least 2 visual function assessments between 1 year and 3 years (+/- 4 weeks) after vision loss;
•Subjects who are willing and able to provide written informed consent if required as per local regulations;
•For LHON subjects under the age of 18 years, permission from a legal guardian to participate in the study;

Exclusion Criteria

•Subjects who received any investigational drug, or participated in any LHON-related interventional clinical trial during the observational period;
•Subjects without medical charts data available.

Locations (11)

Doheny Eye Center UCLA Pasadena

Pasadena, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Wills Eye Institute

Philadelphia, Pennsylvania, United States

Alkek Eye Center

Houston, Texas, United States

CHU d'Angers

Angers, France

CHNO Les Quinze Vingts

Paris, France

Ospedale Bellaria

Bologna, Italy

Ospedale San Raffaele

Milan, Italy

Institut Catala de Retina

Barcelona, Spain

Key Dates

Start Date

January 3, 2018

Primary Completion Date

July 1, 2020

Completion Date

July 1, 2020

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Leber Hereditary Optic Neuropathy

Interventions

Patient-reported outcomes (PROs)

OTHER

Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year

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Leber Hereditary Optic Neuropathy

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TERMINATEDPHASE1/PHASE2

Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND1 Mutations

NCT05820152

Leber Hereditary Optic Neuropathy (LHON)

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UNKNOWNPHASE2/PHASE3

A Single Intravitreal Injection of rAAV2-ND4 for the Treatment of Leber's Hereditary Optic Neuropathy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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