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Optic Atrophy, Hereditary, Leber clinical trials

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NCT ID: NCT05555784 Completed - Clinical trials for Leber's Hereditary Optic Neuropathy (LHON)

Evaluation of Impact of Disease and Visual Disability on Quality of Life and Loss of Independence of Patients Living in France With Leber's Hereditary Optic Neuropathy (LHON) Through Qualitative and Quantitative Data Collection

Start date: August 4, 2022
Phase:
Study type: Observational

Leber's hereditary optic neuropathy (LHON) is a rare mitochondrial genetic disorder characterized by optic nerve atrophy due to the degeneration of retinal ganglion cells, which leads to acute visual loss. Males are more likely to develop optic neuropathy than women. They experience blurring or clouding of vision in one eye. The fellow eye develops similar symptoms sequentially with a delay of weeks. This sudden vision loss has devastating consequences on the life course of young men, with the impact of LHON on their quality of life and loss of independence. Yet, data describing the impacts of LHON on the life-course of patients is lacking, with very little data available in the literature. This study aims to understand the life of patients living with LHON disease through the analysis of the impact of LHON on the quality of life and loss of independence of patients living in France and to accurately describe the consequences of the disease on their social, familial and professional life.

NCT ID: NCT04909398 Completed - Clinical trials for Retinitis Pigmentosa

Pupil Dynamics and Color Vision for the Detection of Eye Diseases

PupDyn
Start date: March 22, 2018
Phase: N/A
Study type: Interventional

The development of new oculometry techniques allows fine and dynamic measurements of pupillary diameter and use in routine clinical practice. The preliminary results obtained with innovative devices on healthy sjuets make it possible to envisage a clinical study on a population of patients suffering from retinal pathologies. This is a "proof of concept" study, which, if the expected results are confirmed, will make it possible to consider a study on a larger population, as well as the industrial development of a commercial device.

NCT ID: NCT04561466 Completed - Safety Issues Clinical Trials

Trial of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy

Béfinohl
Start date: March 26, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations

NCT ID: NCT03406104 Completed - Clinical trials for Leber Hereditary Optic Neuropathy

RESCUE and REVERSE Long-term Follow-up

RESTORE
Start date: January 9, 2018
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4 mitochondrial mutation and who were treated in the Rescue or Reverse studies.

NCT ID: NCT03295071 Completed - Clinical trials for Leber Hereditary Optic Neuropathy

REALITY LHON Registry

REALITY
Start date: January 3, 2018
Phase:
Study type: Observational [Patient Registry]

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).

NCT ID: NCT02796274 Completed - Clinical trials for Leber's Hereditary Optic Neuropathy (LHON)

Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

Start date: May 2016
Phase:
Study type: Observational

The purpose of this survey is to collect visual acuity data from patients with LHON in order to establish the clinical course (natural history) and visual acuity outcomes in patients with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data that will serve as comparator for the open-label study SNT-IV-006.

NCT ID: NCT02774005 Completed - Clinical trials for Leber's Hereditary Optic Neuropathy (LHON)

Study to Assess the Efficacy and Safety of Raxone in LHON Patients

LEROS
Start date: May 2016
Phase: Phase 4
Study type: Interventional

LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy and safety of Raxone® in the long-term treatment of LHON patients.

NCT ID: NCT02771379 Completed - Clinical trials for Leber's Hereditary Optic Neuropathy (LHON)

Post Authorisation Safety Study With Raxone in LHON Patients

PAROS
Start date: September 2016
Phase:
Study type: Observational

This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®. No medication will be provided as part of this study. Raxone® will be obtained through commercial channels.

NCT ID: NCT02693119 Completed - Clinical trials for Leber's Hereditary Optic Neuropathy

A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy

Start date: March 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, prospective, randomized, double-masked, vehicle controlled, single-center study in approximately 12 subjects with LHON to evaluate safety, tolerability and efficacy of elamipretide (MTP-131) topical ophthalmic solution in this patient population. At the conclusion of 52 weeks of treatment, subjects will be offered the opportunity to enter an Open Label Extension for up to 48 additional weeks of treatment.

NCT ID: NCT02064569 Completed - Clinical trials for Leber Hereditary Optic Neuropathy

Safety Evaluation of Gene Therapy in Leber Hereditary Optic Neuropathy (LHON) Patients

Start date: February 13, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability profile of ascending doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.