Abstract Details

Title Technical Feasibility of Implementing Multifocal VEP for Multicenter Clinical Trials

Topic Neuro-ophthalmology/Neuro-otology

Presentation(s) P02 - (-)

Poster/Presentation
Number 245

Objective

Background BACKGROUND: Multiple sclerosis (MS) often presents as acute optic neuritis (ON), reflecting optic nerve demyelination. Multifocal visual evoked potentials (mfVEP) can identify a range of optic nerve damage, including demyelination, and may detect remyelination.

Design/Methods DESIGN/METHODS: mfVEP evaluation was performed on 8 male, 8 female subjects (8 normal controls; 8 ON patients (6 with MS) at 2 international sites: 8 subjects per site). Two tests were performed per subject within 7-10 days. Usable traces were required in 80% of segments/eye. Analyses included the proportion of identifiable responses, test-retest reliability, latency comparisons between subject groups and between affected/ fellow eyes in ON patients and performance by study site. Object from Motion (OFM) tests were performed in Israel.

Results RESULTS: A median 95% mfVEP responses was identifiable in each site. Test-retest reliability was high (R^2=0.98 for both right and left eyes). Compared with the latency in control eyes (mean +/- standard deviation, 145.9 +/- 4.6 msec), latencies for affected eyes (165.8 +/- 13.2) and fellow eyes (151.1 +/- 6.2) of ON patients were significantly longer (P<0.00001 and P=0.002, respectively). Performance was similar between study sites. Asymmetry with OFM correlated with asymmetry of mfVEP (R^2=0.31).

Conclusions CONCLUSIONS: mfVEP demonstrated intra-site and inter-site reliability and reproducibility. Latencies in control eyes were significantly different from affected and fellow eyes of ON patients. These data support the use of mfVEP as a tool in multicentre clinical trials to assess damage from central nervous system demyelination. mfVEP may be also be useful to measure remyelination during natural recovery or in clinical trials of remyelinating therapies. Based on these data, mfVEP may be an efficacy end point in the phase 2 multicenter trial of the anti-LINGO-1 compound BIIB033.

Authors/Disclosures
Diego Cadavid, MD, FAAN (Verge Genomics) PRESENTER	Dr. Cadavid has received personal compensation for serving as an employee of Verge Genomics. Dr. Cadavid has received personal compensation for serving as an employee of Vertex Pharmaceuticals. Dr. Cadavid has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novo Nordisk. Dr. Cadavid has or had stock in Verge Genomics.Dr. Cadavid has or had stock in Vertex Pharmaceuticals.
	No disclosure on file
Fiona E. Costello, MD (Fiona Costello Professional Corporation)	Dr. Costello has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Costello has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Costello has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Costello has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Costello has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Accure Therapeutics. Dr. Costello has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for the Sumaira Foundation.
	No disclosure on file
Alexandr Klistorner	Alexandr Klistorner has nothing to disclose.
Susan A. Eaton, PharmD (AbbVie)	No disclosure on file

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