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

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ClinicalTrials.gov Identifier: NCT04686110
Recruitment Status : Not yet recruiting
First Posted : December 28, 2020
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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
Amyotrophic Lateral Sclerosis Other: angiographic optical coherence tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023


Arm Intervention/treatment
Patients Amyotrophic Lateral Sclerosis Other: angiographic optical coherence tomography
angiographic optical coherence tomography

Control subjects Other: angiographic optical coherence tomography
angiographic optical coherence tomography




Primary Outcome Measures :
  1. Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls [ Time Frame: at inclusion ]
    Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04686110    
Other Study ID Numbers: 2020-AO3395-34
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Neovascularization, Pathologic
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Metaplasia