Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT06796504
Eligibility Criteria:
Inclusion Criteria:
* Age 22-55 years at informed consent.
* Diagnosis of RRMS by revised 2017 McDonald criteria.
* Latency delay \>118 milliseconds on baseline full-field transient pattern reversal visual evoked potential (VEP) in at least one eye. Both eyes can be included if they meet all inclusion criteria.
* Peri-papillary retinal nerve fiber layer (pRNFL) \> 70 microns on Optical Coherence Topography (OCT) in the VEP-qualifying eye (sufficient axons).
* Best corrected high-contrast visual acuity (HCVA) better than LogMAR 1.0 by ETDRS (20/200 Snellen equivalent or letter score of 35).
* Best corrected low-contrast letter acuity (LCLA) by Sloan chart (2.5% black on white) of no better than 40 letters in the VEP-qualifying eye (Snellen equivalent of 20/40). (Best corrected LCLA must be worse than best corrected HCVA.)
* Absence of clinical relapse and/or no sign of MRI activity (1 or more gadolinium enhancing lesions or new T2 lesion developments) for at least 12 months prior to study enrollment while on a stable regimen of high potency disease-modifying therapy (DMT) prior to informed consent: if low-potency DMT, the DMT must have been started and maintained for at least two years prior to consent. If high-potency DMT, DMT must have been started and maintained at least one year prior to consent.
* Score of 2.5 to 6.0 by Expanded Disability Status Scale (EDSS) at baseline, with at least of 2 on the functional systems pyramidal function.
Exclusion Criteria:
* Confounding ophthalmologic disease or impairments/conditions that could interfere with visual testing (e.g., cataracts, disc hemorrhage, macular star, cotton wool spots, macular degeneration, glaucoma, etc.).
* Concurrent neurological disorders, including known moderate or severe cervical myelopathy.
* Clinical optic neuritis within 6 months before screening.
* Documented optic neuritis in the qualifying eye greater than 5 years before screening.
* Change in DMT within 1 year (High-potency DMT) or 2 years (Low-potency DMT) before consent.
* Glucocorticoid use within 30 days before consent.
* Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI (e.g., claustrophobia).
* Regular use of or dependency on nicotine products within the past year.
* Not a surgical candidate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
55 Years
Study:
NCT06796504
Study Brief:
Protocol Section:
NCT06796504