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Yasir Jamal Sepah, Quan Dong Nguyen, Diana V Do, Bann-mo Day, Eric Wakshull, Ivaylo Stoilov; Trends for poorer vision outcomes in nAMD and DME patients with higher aqueous humor levels of IL-6. Invest. Ophthalmol. Vis. Sci. 2019;60(9):4938.
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To measure the interleukin 6 (IL-6) levels in the aqueous humor of patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); Compare vison outcomes with anti-vascular endothelial growth factor (anti-VEGF) monotherapy between “high” and “low” IL-6 concentration groups.
In the READ3 study 152 patients with DME were randomized 1:1 to receive 0.5 mg or 2.0 mg ranibizumab q4 for 24 months. Aqueous humor samples from 131 eyes were collected at baseline, Months 3, 6, 9 and 12. In the HARBOR study 1097 patients with nAMD were randomized 1:1:1:1 to receive 0.5 mg or 2.0 mg ranibizumab q4 or PRN for 24 months. Matching aqueous and serum samples collected at study month 2 (after the third monthly/loading ranibizumab injection) were available from 36 patients. Functional outcomes were assessed as change from baseline in BCVA (ETDRS letters). Wilcoxon rank-sum test was used to compare concentrations. Spearman rank correlation coefficient was used to evaluate correlations between IL-6 levels and functional outcomes.
IL-6 levels did not appear to be affected by VEGF inhibition. After 3 ranibizumab injections the median IL-6 concentration in aqueous humor was 24.7 pg/ml in patients with DME and 6.0 pg/ml in patients with nAMD. There was no correlation between aqueous and serum IL-6 levels in patients with nAMD. In READ3 at all time points there appears to be a negative correlation between the baseline IL-6 level and BCVA: the higher the baseline IL-6 levels rank, the lower the BCVA levels tend to rank at every time point (Figure 1). In the HARBOR trial nAMD patients with the highest aqueous IL-6 levels on average lost 9 BCVA letters by the end of the study, while the rest of patients maintained vision (Figure 2).
Analyses from two different groups of patients with DME and nAMD identify potential trend of poorer vision outcomes with anti-VEGF monotherapy in patients with higher aqueous levels of IL-6.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
READ3: Change in BCVA from baseline by IL-6 Levels (High = top 25%; Low = bottom 75%)
HARBOR: Change in BCVA from month 2 by IL-6 Levels (High = top 25%; Low = bottom 75%)
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