Using retinal markers to predict disease progression in neuroinflammatory diseases
Retinal Markers in Neuroinflammatory Diseases: a Prospective Observational Study
This study is testing if eye exams can help predict how Multiple Sclerosis and other neuroinflammatory diseases will progress in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06369766 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the predictive value of retinal markers in patients with Multiple Sclerosis and other neuroinflammatory diseases, as well as healthy controls. Participants will undergo non-invasive retinal examinations and complete a questionnaire to assess various retinal measures. The focus is on identifying neuroaxonal loss and neuroinflammation in the retina, which may indicate progression independent of relapse activity (PIRA). The study seeks to improve early identification of patients at risk for PIRA, which is crucial for effective management of Multiple Sclerosis.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with Multiple Sclerosis or other neuroinflammatory diseases.
Not a fit: Patients with significant ocular pathology or those unable to undergo Optical Coherence Tomography (OCT) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of disease progression in patients with neuroinflammatory diseases, allowing for better therapeutic decisions.
How similar studies have performed: While the use of retinal markers in this context is promising, the specific predictive value for PIRA in neuroinflammatory diseases is still being explored and may represent a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Basel
- University Hospital Basel, Department of Neurology — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Athina Papadopoulou, PD Dr. med. — University Hospital Basel, Department of Neurology
- Study coordinator: Athina Papadopoulou, PD Dr. med.
- Email: Athina.Papadopoulou@usb.ch
- Phone: +41 61 32 85704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.