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

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

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 Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Other: angiographic optical coherence tomography

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Attachée de Recherche Clinique; Phone Number: 0241353637; Email: jeanne.muller@chu-angers.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • Chu Angers
    • Contact: Jeanne Muller; Phone Number: 0241353637

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control subjects	Other: angiographic optical coherence tomography; angiographic optical coherence tomography
Other: Patients Amyotrophic Lateral Sclerosis	Other: angiographic optical coherence tomography; angiographic optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metaplasia; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neovascularization, Pathologic
• Other Study ID Numbers: 2020-AO3395-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No