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:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01851434
Eligibility Criteria:
* INCLUSION CRITERIA:
COHORT 1: Unilateral optic neuritis.
* Typical demyelinating optic neuritis based on the best clinical judgment of the investigators.
* Symptom onset within 46 weeks of enrollment OR patients with history of optic neuritis who were followed from symptom onset under a Neuroimmunology Branch natural history or screening protocol.
* For women of childbearing potential, willing to use acceptable forms of contraception (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods (condom or diaphragm) with spermicide or they have undergone surgical sterilization (hysterectomy, tubal ligation, or vasectomy in a partner) for the study duration.
* Able to provide informed consent.
* Willing and able to participate in all aspects of the trial.
COHORT 2: Healthy volunteers.
* No medical history that would interfere with study result interpretation, in the best clinical judgment of the investigators.
* Age greater than or equal to 18 years and less than or equal to 50 years.
* Able to provide informed consent.
* Willing and able to participate in all aspects of the trial.
EXCLUSION CRITERIA:
* History of signs or symptoms suspicious for MS, in the best clinical judgment of the investigators.
* Pateints-Disease-modifying therapy for MS prior to the onset of the current episode of optic neuritis (excludes oral or intravenous glucocorticoids: Healthy Volunteers - Previous or current use of disease-modifying therapy for MS (excluding oral or intravenous glucocorticoids.
* Previous history of clinical optic neuritis or a systemic disease associated with optic neuritis (e.g. sarcoidosis, lymphoma).
* Current or prior optic neuropathy (e.g. trauma, ischemia, glaucoma, optic nerve drusen).
* Previous history of a retinal disease (e.g. diabetic retinopathy, retinal drusen) other than uveitis.
* Previous history of an ophthalmic disease that in the best judgment of the investigator could affect ophthalmic imaging results.
* Previous history of a systemic disease that may mimic MS (e.g. neurosyphilis, neurosarcoidosis, CNS ymphoma, Si(SqrRoot)(Delta)gren s syndrome).
* Previous history of a systemic disease that in the best judgment of the investigator could confound study outcome.
* Current use of a TNF-alpha inhibitor (e.g. etanercept).
* Habitual use of illicit drugs that in the best judgment of the investigators could confound study outcome.
* Pregnant or breast-feeding.
* Unwilling to co-enroll on a Neuroimmunology Branch natural history or screening protocol currently 89-N-0045.
* Contraindication to MRI scanning.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01851434
Study Brief:
Protocol Section:
NCT01851434