Abstract Details

Title Retinal Structure and Function as a Predictor of Long-Term Visual Outcomes: A Post Hoc Analysis of RENEW and RENEWED

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 096

Objective Determine whether structural/functional change in retinal ganglion cell layer (RGCL) and retinal nerve fiber layer (RNFL) may predict long-term visual outcomes in multiple sclerosis (MS).

Background Visual function at baseline may predict subsequent development of abnormal visual function in MS.

Design/Methods RENEW (NCT01721161) was a randomized, placebo-controlled study of participants with first-episode acute optic neuritis who were treated with opicinumab 100 mg/kg Q4W (6 doses) or placebo and followed-up to week 32 (Wk32). Participants were enrolled in RENEWED (NCT02657915), a 1-day follow-up 2 years after RENEW end of study, to investigate the long-term electrophysiologic and clinical outcomes of treatment with opicinumab vs. placebo. SD-OCT was used to evaluate changes in structure of RGCL/inner plexiform layer (IPL) and RNFL from RENEW baseline to Wk32 in the fellow and affected eyes. Changes in visual function were assessed using full-field visual evoked potential (FF-VEP) and multifocal VEP (mfVEP), object from motion (OFM) and number from motion (NFM) tests, high-contrast visual acuity (HCVA), and low-contrast letter acuity (LCLA, 1.25% and 2.5%). The same visual outcomes were re-evaluated in RENEWED. Linear regression analysis was performed.

Results The number of RENEW participants who completed RENEWED were 52/82 in the ITT population (opicinumab, n=28; placebo, n=24). Change in RGCL/IPL from RENEW BL fellow eye to Wk32 affected eye was predictive of HCVA, LCLA (1.25% and 2.5%), OFM and NFM in the affected eye in RENEWED (p≤0.04). Changes in both RGCL/IPL and RNFL from RENEW BL to Wk32 in the affected eye were predictive of HCVA, LCLA, and OFM in the affected eye in RENEWED (p≤0.04) but not of NFM. Change in RNFL from BL fellow eye to Wk32 affected eye was predictive of only LCLA (1.25% and 2.5%) of the affected eye in RENEWED (p≤0.02).

Conclusions

Changes in the RGCL/IPL and RNFL are predictive of long-term visual outcomes.

Supported by: Biogen

Authors/Disclosures
Steven Galetta, MD, FAAN (NYU Langone Medical Center) PRESENTER	Dr. Galetta has nothing to disclose.
Laura J. Balcer, MD, MSCE, FAAN (NYU Grossman School of Medicine)	An immediate family member of Dr. Balcer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Children's Hospital of Philadelphia.
	No disclosure on file
	No disclosure on file
Orhan Aktas, MD (Neurologische Klinik)	Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen/Horizon. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubish Tanake. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AstraZeneca. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Aktas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen/Horizon. The institution of Dr. Aktas has received research support from German Research Foundation. The institution of Dr. Aktas has received research support from German Ministry of Science. The institution of Dr. Aktas has received research support from Neuromyelitis optica Study Group (NEMOS).
Maria Naylor, PhD	Dr. Naylor has received personal compensation for serving as an employee of Dyne Therapeutics. Dr. Naylor has stock in Biogen. Dr. Naylor has stock in Dyne Therapeutics.

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