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

Amyotrophic Lateral Sclerosis Clinical Trial

— CAPISLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686110
• Other study ID #: 2020-AO3395-34
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: February 2023

Study information

• Verified date: October 2021
• Source: University Hospital, Angers
• Contact: Attachée de Recherche Clinique
• Phone: 0241353637
• Email: jeanne.muller[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Neovascularization, Pathologic
• Sclerosis

Intervention

Other:
• angiographic optical coherence tomography
angiographic optical coherence tomography

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls	Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls	at inclusion