Clinical trials: Optic Neuropathies
Leber Hereditary Optic Neuropathy
Safety Evaluation of Gene Therapy in Leber Hereditary Optic Neuropathy (LHON) Patients
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.
- Trial name
- NCT02064569
- Testing
- GS010
- Where
- France
- Volunteers
- 19 people
- Sponsor
- GenSight Biologics
Leber Hereditary Optic Neuropathy
REALITY LHON 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…
- Trial name
- REALITY (NCT03295071)
- Testing
- Patient-reported outcomes (PROs)
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 44 people
- Sponsor
- GenSight Biologics
Leber Hereditary Optic Neuropathy
RESCUE and REVERSE Long-term Follow-up
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…
- Trial name
- RESTORE (NCT03406104)
- Testing
- GS010
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 62 people
- Sponsor
- GenSight Biologics
Leber Hereditary Optic Neuropathy (Optic, Atrophy, Hereditary, Leber)
EAP_GS010_single Patient
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
- Trial name
- NCT03672968
- Testing
- GS010
- Sponsor
- GenSight Biologics
Optic Neuropathy
Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
The purpose of this study is to test the efficacy and feasibility of an intervention protocol for home-based repetitive transorbital alternating current stimulation (rtACS) for the treatment of visual impairment in people with…
- Trial name
- NCT06662448
- Testing
- SAVIR Alpha Synch mobile (SASm)
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Leber Hereditary Optic Neuropathy (LHON)
A Phase 3, Multicenter, Randomized, Double-Masked, Sham-Controlled Clinical Trial for Leber's Hereditary Optic Neuropathy (LHON) Associated With ND4 Mutation
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.
- Trial name
- NCT07406854
- Testing
- rAAV2-ND4
- Where
- China
- Volunteers
- 95 people
- Sponsor
- Wuhan Neurophth Biotechnology Limited Company
Mitochondrial Disorders, Mitochondrial Genetic Disorders
North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC)
The North American Mitochondrial Disease Consortium (NAMDC) maintains a patient contact registry and tissue biorepository for patients with mitochondrial disorders.
- Conditions
- Mitochondrial Disorders, Mitochondrial Genetic Disorders, Mitochondrial Diseases, Disorder of Mitochondrial Respiratory Chain Complexes
- Trial name
- NAMDC (NCT01694940)
- Where
- 17 sites in United States, Canada
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Columbia University
Nonarteritic Anterior Ischemic Optic Neuropathy
Platelet-Rich Plasma for Acute Nonarteritic Anterior Ischemic Optic Neuropathy: A Prospective Randomized Controlled Study
This prospective randomized clinical study aims to evaluate the efficacy and safety of autologous platelet-rich plasma (PRP) injection in patients with acute non-arteritic anterior ischemic optic neuropathy (NAION).
- Trial name
- PRP-NAION (NCT07330713)
- Testing
- Autologous Platelet-Rich Plasma (PRP)
- Where
- Turkey (Türkiye)
- Volunteers
- 31 people
- Sponsor
- Uludag University
Leber Hereditary Optic Neuropathy (LHON), Leber's Hereditary Optic Neuropathy (LHON)
Pilot Study of the Efficacy of Nicotinamide (Vitamin B3) in Leber's Hereditary Optic Neuropathy
Leber Hereditary Optic Neuropathy (LHON) is a rare genetic disease that causes sudden and severe vision loss, usually in young adults.
- Conditions
- Leber Hereditary Optic Neuropathy (LHON), Leber's Hereditary Optic Neuropathy (LHON), Mitochondrial Disease, Optic Nerve Disease
- Trial name
- NICOLHON (NCT07258667)
- Testing
- Nicotinamide treatment
- Where
- France
- Volunteers
- 13 people
- Sponsor
- University Hospital, Angers
Healthy Subjects, Leber Hereditary Optic Neuropathy
Metabolomics Analysis According to the Retinal Nerve Fiber Layer in Patients With NOHL Mutations (MétabOCT)
Leber hereditary optic neuropathy (LHON), due to mitochondrial DNA (mtDNA) mutations, is responsible for profound visual impairment. However, there is evidence that optic nerve damage begins before vision declines.
- Trial name
- MétabOCT (NCT06682819)
- Testing
- Optical coherent tomography
- Where
- France
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Hôpital Necker-Enfants Malades
Optic Neuropathy, Optic Neuropathy, Ischemic
Building Research With Artificial Intelligence in Neuro-Ophthalmology
The research team, recognized as a world leader in Artificial Intelligence for neuro-ophthalmology, has shown that it is possible to diagnose certain neuro-ophthalmologic or neurologic disorders from a single retinal fundus image…
- Conditions
- Optic Neuropathy, Optic Neuropathy, Ischemic, Optic Neuritis, Optic Nerve Diseases
- Trial name
- BRAIN (NCT06390579)
- Testing
- Deep learning algorithm applied on retrospectively collected color fundus photographs
- Where
- France
- Volunteers
- 693 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
Chronic Optic Neuropathy in Multiple Sclerosis
CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS
Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any acute demyelinating lesion of the optic…
- Trial name
- NCT02543788
- Testing
- • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG
- Where
- France
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Adult Patients Developing Optic or Peripheral Neuropathy, While Receiving Tedizolid Therapy Between July 2019 and December 2024
Tedizolid Neuropathies
Tedizolid is a new oxazolidinone, related to linezolid. It has obtained marketing authorization for the treatment of skin and soft tissue infections.
- Trial name
- NCT07143240
- Testing
- Determine patient demographic and clinical characteristics at baseline
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Hospices Civils de Lyon
Neuro-Ophthalmology, Optic Neuropathies
Optic Nerve Head Evaluation Through Multimodal Blood Flow Analysis: a Prospective Observational, Multi-center Study
OCT-A and eco-colordoppler are technologies which enable optic nerve head (ONH) blood perfusion detection. The aim of the study is to assess ONH vascular and structural components in optic neuropathies with and without ONH edema…
- Conditions
- Neuro-Ophthalmology, Optic Neuropathies, Optic Atrophy, Hereditary, Leber, Optic Neuropathy, Anterior Ischemic
- Trial name
- FlowONH (NCT07075887)
- Volunteers
- 70 people
- Sponsor
- Barboni
Obstructive Sleep Apnea (OSA), Ischemic Optic Neuropathy/Optic Nerve Stroke
Optic Nerve Injury in Obstructive Sleep Apnea Patients
Ischemic optic neuropathy (ION) is damage to the optic nerve caused by ischemia and hypoxia of the optic nerve due to an impairment of the blood supply to the optic nerve from the arteries.
- Trial name
- NCT06748703
- Testing
- CPAP Treatment
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Nanjing Medical University
Leber's Hereditary Optic Neuropathy
Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy
The study is a dose-escalation study, phase 1. The objective of this proposed clinical trial is to evaluate the safety of mitochondrially targeted ND4 gene therapy with the adeno-associated viral vector in appropriate LHON…
- Trial name
- LHON (NCT02161380)
- Testing
- injection of scAAV2-P1ND4v2 1.18x10e9 vg (Low),, injection of scAAV2-P1ND4v2 5.81 X10e9 vg (Med), injection of scAAV2-P1ND4v2 2.4 X10e10vg (High)
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Byron Lam
Glaucoma, Macular Degeneration
BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
The purpose of this research study is to better understand the impact of visual impairment caused by different eye diseases on the ability to perform daily activities and compare it to that in patients without eye diseases.
- Conditions
- Glaucoma, Macular Degeneration, Glaucoma Suspect, Optic Neuropathy
- Trial name
- NCT03318549
- Testing
- Visual Performance tests, Brain-computer interface
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- University of Miami
Non-arteritic Ischemic Optic Neuropathy, Optic Disk Drusen
NA-AION Risk Factors: New Perspectives
The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION.
- Trial name
- NARROW (NCT05305079)
- Where
- 20 sites in United States, Australia and 7 more
- Volunteers
- 179 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Leber Hereditary Optic Neuropathy (LHON)
Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND1 Mutations
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.
- Trial name
- NCT05820152
- Testing
- NFS-02 Injection
- Where
- 4 sites in United States, China
- Volunteers
- 11 people
- Sponsor
- Neurophth Therapeutics Inc
Leber Hereditary Optic Neuropathy (LHON)
Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND4 Mutations
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.
- Trial name
- NCT05293626
- Testing
- NR082 Injection, Injection needle
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Neurophth Therapeutics Inc