AUTHOR=Klumbies Katharina , Rust Rebekka , Dörr Jan , Konietschke Frank , Paul Friedemann , Bellmann-Strobl Judith , Brandt Alexander U. , Zimmermann Hanna G. 

TITLE=Retinal Thickness Analysis in Progressive Multiple Sclerosis Patients Treated With Epigallocatechin Gallate: Optical Coherence Tomography Results From the SUPREMES Study

JOURNAL=Frontiers in Neurology

VOLUME=12

YEAR=2021

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.615790

DOI=10.3389/fneur.2021.615790

ISSN=1664-2295

ABSTRACT=<p><bold>Background:</bold> Epigallocatechin gallate (EGCG) is an anti-inflammatory agent and has proven neuroprotective properties in animal models of multiple sclerosis (MS). Optical coherence tomography (OCT) assessed retinal thickness analysis can reflect treatment responses in MS.</p><p><bold>Objective:</bold> To analyze the influence of EGCG treatment on retinal thickness analysis as secondary and exploratory outcomes of the randomized controlled <italic>Sunphenon in Progressive Forms of MS</italic> trial (SUPREMES, NCT00799890).</p><p><bold>Methods:</bold> SUPREMES patients underwent OCT with the Heidelberg Spectralis device at a subset of visits. We determined peripapillary retinal nerve fiber layer (pRNFL) thickness from a 12° ring scan around the optic nerve head and thickness of the ganglion cell/inner plexiform layer (GCIP) and inner nuclear layer (INL) within a 6 mm diameter grid centered on the fovea from a macular volume scan. Longitudinal OCT data were available for exploratory analysis from 31 SUPREMES participants (12/19 primary/secondary progressive MS (PPMS/SPMS); mean age 51 ± 7 years; 12 female; mean time since disease onset 16 ± 11 years). We tested the null hypothesis of no treatment<sup>*</sup>time interaction using nonparametric analysis of longitudinal data in factorial experiments.</p><p><bold>Results:</bold> After 2 years, there were no significant differences in longitudinal retinal thickness changes between EGCG treated and placebo arms in any OCT parameter (Mean change [confidence interval] ECGC vs. Placebo: pRNFL: −0.83 [1.29] μm vs. −0.64 [1.56] μm, <italic>p</italic> = 0.156; GCIP: −0.67 [0.67] μm vs. −0.14 [0.47] μm, <italic>p</italic> = 0.476; INL: −0.06 [0.58] μm vs. 0.22 [0.41] μm, <italic>p</italic> = 0.455).</p><p><bold>Conclusion:</bold> Retinal thickness analysis did not reveal a neuroprotective effect of EGCG. While this is in line with the results of the main SUPREMES trial, our study was probably underpowered to detect an effect.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="http://www.ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">www.ClinicalTrials.gov</ext-link>, identifier: NCT00799890.</p>