Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab
Launched by JOHNS HOPKINS UNIVERSITY · Dec 4, 2023
Trial Information
Current as of November 06, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is watching people with relapsing multiple sclerosis (MS) who are about to start or are already taking the medicine ofatumumab. Researchers want to see if the rhythm of retinal (eye) thinning and other eye changes over two years relates to levels of a blood marker called neurofilament light chain (sNfL), which can reflect nerve damage. The main question is whether retinal changes differ by baseline sNfL levels, and the study will also look at other eye and vision measures. It’s an observational study, not a test of the drug itself, and it includes about 75 people with MS and comparison data from healthy controls.
People can join if they are adults between 18 and 70 with relapsing MS and are planning to start ofatumumab within 60 days of baseline tests or are already receiving it. Exclusions include uncontrolled diabetes or high blood pressure, glaucoma, very large refractive errors, or other nerve or eye conditions. Participants will be followed for two years with visits every six months, including eye imaging (OCT), vision tests, disability scoring (EDSS), and a blood test for sNfL, plus some additional vision tests. The study is led by Johns Hopkins University in Baltimore, with Novartis as a collaborator, and aims to help doctors understand how eye changes relate to this MS treatment and nerve health.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Between 18 - 70 years of age
- • 2. Have RMS as confirmed by the treating neurologist based on the 2017 revised McDonald criteria
- • AND Either
- • be due to commence ofatumumab within 60 days of baseline OCT/VA/phlebotomy or
- • be existing patients attending the center and already receiving ofatumumab, be eligible for inclusion, and already undergoing all of the proposed study procedures.
- • 3. Willing to sign informed consent
- • 4. Willing to undergo phlebotomy
- Exclusion Criteria:
- • Uncontrolled Diabetes
- • Uncontrolled Hypertension
- • Glaucoma
- • Refractive errors of +/- 6 diopters
- • Other neurologic or ophthalmologic disorders
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Shiv Saidha, MBBCh
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported