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

Sponsor
University Hospital, Angers (Other)
Overall Status
Recruiting
CT.gov ID
NCT04686110
Collaborator
(none)
94
1
2
23.6
4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: angiographic optical coherence tomography
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date :
Feb 12, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Patients Amyotrophic Lateral Sclerosis

Other: angiographic optical coherence tomography
angiographic optical coherence tomography

Other: Control subjects

Other: angiographic optical coherence tomography
angiographic optical coherence tomography

Outcome Measures

Primary Outcome Measures

  1. Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls [at inclusion]

    Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Angers Angers France 49933

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT04686110
Other Study ID Numbers:
  • 2020-AO3395-34
First Posted:
Dec 28, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021