MSFrontier

REtinal Markers In Neuroinflammatory Diseases ("REMIND")

Retinal Markers in Neuroinflammatory Diseases: a Prospective Observational Study
RecruitingMS (type not specified)NCT06369766

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Optical coherence tomography (OCT)
  • Static retinal vessel analyzer
  • Dynamic retinal vessel analyzer
  • Laser speckle flowgraphy system
  • Questionnaire

What it measured

Main measures

  • Occurence of Progression Independent of Relapse Activity (PIRA)

    5 Years (or for a subgroup up to 10 years) after baseline

    Disability progressionRelapses

  • Neuroaxonal loss in the retina (as marker of neurodegeneration in the CNS)

    Baseline and once every year over up to 5 years

    Retina scans (OCT)

  • Neuroinflammation in the retina

    Baseline and once every year over up to 5 years

    Retina scans (OCT)

  • Fixation instability (as marker of global neuronal dysfunction in the CNS)

    Baseline and once every year over up to 5 years

    Retina scans (OCT)

  • Structural changes of the retinal vessels (as marker of systemic microvascular health)

    Baseline and once every year over up to 5 years

  • (For a subgroup of participants) Functional/perfusional changes of the retinal vessels

    Baseline and once every year over up to 5 years

    Retina scans (OCT)

Other measures (3)

  • Relative value of retinal markers for the prediction of PIRA compared to or combined with other biomarkers of neuroaxonal damage

    Baseline and once every year over up to 5 years

    Disability progressionBrain volume lossBlood or spinal fluid markers

  • Comparison of the examined retinal markers of Multiple Sclerosis patients with Healthy Controls and with patients with other neuroinflammatory diseases of the CNS

    Baseline and once every year over up to 5 years

  • The relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis

    Baseline and once every year over up to 5 years

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: 1. All groups: * Age >18 years old 2. Patients with Multiple Sclerosis: * Diagnosis of Multiple Sclerosis, according to the last revisions of the McDonald Criteria (2017) 3. Patients with other neuroinflammatory diseases: * Diagnosis of Neuromyelitis optica spectrum disorder or Myelin oligodendrocyte glycoprotein antibody disease or other neuroinflammatory disorders other than Multiple Sclerosis Exclusion Criteria: 1. All groups: * Inability to undergo Optical Coherence Tomography (OCT) and/or retinal vessel imaging (e.g. severe nystagmus that prevents eye fixation on both eyes) * Presence of any ocular pathology that may interfere with the validity of the OCT/retinal vessel analysis (cataracts, glaucoma, history of refractive defects >6 D etc.). * Pregnancy and Lactation 2. Healthy Controls * History of other neurological conditions: participants with a history of other significant neurological conditions that might interfere with the assessment or interpretation of the signs and symptoms will be excluded (e.g. confirmed Stroke, Acute disseminated encephalomyelitis, Chronic inflammatory Demyelinating Disease, Polyneuropathy, etc.)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The goal of this observational study, including patients with Multiple Sclerosis, patients with other neuroinflammatory diseases and healthy controls, is to determine the predictive value of retinal markers in predicting disease progression. Participants complete a questionnaire and undergo various non-invasive retinal routine clinical examinations.

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History

    1. Started

      Jan 2024

    2. Main results due

      Dec 2028

    3. Finished

      Feb 2029

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