Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months (GAO)
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|ClinicalTrials.gov Identifier: NCT02017808|
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : December 3, 2014
|Condition or disease|
The primary aim of this study is to explore whether treatment with Copaxone may decrease accumulation of axonal loss, as measured by retinal nerve fiber layer thickness (RNFLT) on optical coherence tomography (OCT) in patients with RRMS over 24 months and compared to a reference population of healthy controls.
The secondary objective of this study is to investigate the effect of GA on total macular volume (TMV) on OCT in patients with RRMS over 24 months. We will also explore how the 24-month changes of RNFLT and TMV on OCT relate to progression of disability, as measured by Expanded Disability Status Scale (EDSS).
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||A Prospective, Observational, Single-blinded, Longitudinal Optical Coherence Tomography Study of Effect of Copaxone (Glatiramer Acetate) on Retinal Nerve Fiber Layer Thickness in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)
- Retinal health in multiple sclerosis patients prescribed copaxone [ Time Frame: 24 months ]Participants will have an OCT retinal health will be determined by degree of axonal loss.
- Measuring disability progression [ Time Frame: 24 months ]Investigating the effect of copaxone on total macular volume on OCT in patients with RRMS. Exploring progression of disability as measured by Expanded Disability Status Scale (EDSS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017808
|United States, New York|
|Buffalo Neuroimaging Analysis Center|
|Buffalo, New York, United States, 14203|
|Principal Investigator:||Robert Zivadinov, MD, PhD||SUNY University at Buffalo|