Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis

Study Purpose:

Amyotrophic Lateral Sclerosis, or Charcot's disease, is a neurodegenerative disease affecting motor neurons. The disease affects between 5 and 10 people per 100,000 in the world, nearly 7,000 patients are affected in France. The only therapeutic treatment available to date in France is riluzole, which slows the progression of the disease. Amyotrophic Lateral Sclerosis is the first degenerative disease affecting motor neurons. However, recent evidence suggests that the impairment extends beyond motor neurons alone.

Optical Coherence Tomography analyzes made it possible to highlight ophthalmologic damage in patients with Amyotrophic Lateral Sclerosis, in particular at the macula and papilla, although some results are contradictory.

No angiographic Optical Coherence Tomography analysis has been performed to date in patients with Amyotrophic Lateral Sclerosis. However, in the hypothesis of microvascular involvement participating in the pathophysiology of neurodegeneration in Amyotrophic Lateral Sclerosis, these examinations could provide relevant clinical and pathophysiological data by studying the retinal microvascularization of patients with the disease.

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

N/A

Intervention Name:

angiographic optical coherence tomography

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

N/A

Clinicaltrials.gov ID:

NCT04686110

Neals Affiliated?

No

Coordinating Center Contact Information

Attachée de Recherche Clinique / email hidden; JavaScript is required / 0241353637

Study Sponsor:

University Hospital, Angers

Estimated Enrollment:

94

Estimated Study Start Date:

02 / 12 / 2021

Estimated Study Completion Date:

02 / 01 / 2023

Posting Last Modified Date:

10 / 08 / 2021

Date Study Added to neals.org:

12 / 28 / 2020

Minimum Age:

18 Years

Maximum Age:

N/A

Inclusion Criteria:

Patient Amyotrophic Lateral Sclerosis :

- Patient diagnosed with bulbar or spinal ALS defined according to El Escorial criteria (probable or certain)

- Hospitalized in a day hospital at the Angers University Hospital as part of his usual follow-up

Control subject :

- Subject not affected by the disease studied and without a history of neurological disease.

- Subject matched in age and sex to a case (patient)

For all participants:

- Major upon inclusion

- Signature of informed consent to participate in the protocol

Exclusion Criteria:

Patient Amyotrophic Lateral Sclerosis and control subject :

- Simultaneous participation in another intervention protocol with an experimental treatment

- Subject unable to express consent

- Known ophthalmologic pathology (maculopathy, glaucoma, optic neuropathy, retinopathy whatever the etiology)

- Diabetic subject

- Cardiovascular history

- Inability to perform the ophthalmological examinations of the study

- Pregnant, lactating or parturient woman

- Subject under duress psychiatric care

- Subject to legal protection

- Subject not affiliated or not beneficiary of a social security scheme

CHU Angers | Recruiting

Jeanne Muller / 0241353637

Angers 49933
France