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Optic Atrophy, Hereditary, Leber clinical trials

View clinical trials related to Optic Atrophy, Hereditary, Leber.

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NCT ID: NCT05820152 Recruiting - Clinical trials for Leber Hereditary Optic Neuropathy (LHON)

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

Start date: August 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this clinical study is to evaluate the safety, tolerability and preliminary efficacy of NFS-02 in the treatment of LHON caused by mitochondrial ND1 gene mutation. This study will enroll subjects aged ≥ 18 years old and ≤ 75 years old to receive a single unilateral intravitreal (IVT) injection of NFS-02 to evaluate its safety, tolerability and preliminary efficacy. The clinical manifestations of all subjects are to be reduced visual acuity caused by LHON associated with ND1 mutation, with laboratory test showing G3460A mutation (a CLIA-certified laboratory) and reduced visual acuity lasted for > 6 months and < 10 years.

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: NCT05293626 Active, not recruiting - Clinical trials for Leber Hereditary Optic Neuropathy (LHON)

Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND4 Mutations

Start date: May 22, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this clinical study is to evaluate the safety and efficacy of NR082 in the treatment of LHON caused by mitochondrial ND4 gene mutation. This study will enroll subjects aged ≥ 18 years old and ≤ 75 years old to receive a single unilateral intravitreal (IVT) injection of NR082 to evaluate its safety and efficacy. The clinical manifestations of all subjects are to be reduced visual acuity caused by LHON associated with ND4 mutation, with laboratory test showing G11778A mutation (a CLIA-certified laboratory) and reduced visual acuity lasted for > 6 months and < 10 years.

NCT ID: NCT04912843 Recruiting - Clinical trials for Leber's Hereditary Optic Neuropathy (LHON)

Gene Therapy Clinical Trial for the Treatment Of Leber's HereDitary Optic Neuropathy

GOLD
Start date: June 18, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this clinical study is to select the optimal dose and evaluate the safety and efficacy of NR082 in treatment of LHON caused by mitochondrial ND4 gene mutation. Part 1 (Phase 1/2) is a safety dose-finding study, which will enroll subjects aged ≥ 18 years old and ≤ 75 years old to receive a single unilateral intravitreal (IVT) injection of NR082 to observe its safety and efficacy. In Part 2 (Phase 3) of the clinical study, the dose recommended after the end of Part 1 is used to further verify the safety and efficacy of the study drug. Part 2 of the study is divided into the safety run-in phase and the randomized, double-blind and control study. Subjects aged ≥ 12 years and ≤ 75 years will be enrolled in the Part 2. The run-in phase will enroll 6 evaluable subjects. After monitoring for at least 6 weeks, if no new safety signals are observed, the clinical trial will enter the randomized, double-blind and control study phase upon approval by the Safety Review Committee(SRC). The clinical manifestation of all subjects is reduced visual acuity caused by LHON associated with ND4 mutation, and central laboratory test showed G11778A mutation (a CLIA-certified laboratory), while the reduced visual acuity lasted for > 6 months and < 10 years.

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: NCT04381091 No longer available - Clinical trials for Leber's Hereditary Optic Neuropathy

Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study

US EAP LHON
Start date: n/a
Phase:
Study type: Expanded Access

Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study

NCT ID: NCT03672968 No longer available - Clinical trials for Leber Hereditary Optic Neuropathy (Optic, Atrophy, Hereditary, Leber)

EAP_GS010_single Patient

Start date: n/a
Phase:
Study type: Expanded Access

Expanded Access Use for a single patient of Bilateral Intravitreal Injection of GS010 in a Single Subject Affected with G11778A ND4 Leber Hereditary Optic Neuropathy

NCT ID: NCT03475173 Recruiting - Hemianopia Clinical Trials

New Non-invasive Modalities for Assessing Retinal Structure and Function

Start date: May 6, 2019
Phase: N/A
Study type: Interventional

This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.

NCT ID: NCT03428178 Active, not recruiting - Clinical trials for Onset Between 12 to 24 Months

Efficacy Study of Gene Therapy for The Treatment of Acute LHON Onset Within Three Months

LHON
Start date: January 8, 2018
Phase: N/A
Study type: Interventional

Efficacy Study of Gene Therapy for The Treatment of Acute Leber's Hereditary Optic Neuropathy (LHON) onset within three months