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Srinivas R Sadda, Avanti Ghanekar, Lauren Hill, Shamika Gune; Relationship between sub retinal fluid (SRF) and vision outcomes in eyes with neovascular age-related macular degeneration (nAMD) in the HARBOR trial. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5189. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To investigate the relationship between the presence or absence of residual SRF and best-corrected visual acuity (BCVA) of 20/40 or better (≥69 letters on the Early Treatment Diabetic Retinopathy Study scale [ETDRS]) in the HARBOR study (NCT00891735) of ranibizumab in nAMD.
Treatment-naïve patients with nAMD were randomized to ranibizumab 0.5 mg or 2.0 mg administered monthly or pro re nata. This analysis included eyes with SRF at baseline (defined as screening, baseline, or week 1) (N = 785; all treatment arms pooled). Analysis outcomes were BCVA and BCVA ≥69 letters in study eyes with SRF (at baseline, month [M] 12, and M24) as a covariate. The post baseline analysis was adjusted by baseline BCVA values.
Among eyes with SRF at baseline, 22.0% and 20.3% had residual SRF at M12 and M24, respectively. Mean BCVA (letters, 95% confidence interval [CI]) at baseline was higher in eyes with residual SRF at M12 (58.8; 57.2, 60.4) and M24 (59.3; 57.8, 60.8) compared with eyes with resolved SRF at M12 (53.5; 52.4, 54.5) and M24 (53.5; 52.5, 54.5). The odds of achieving BCVA ≥69 letters (Snellen equivalent: 20/40 or better) for eyes with residual SRF vs resolved SRF were similar at M12 (Odds ratio: 1.07; 95% CI: 0.72, 1.59) and M24 (1.14; 0.77, 1.68), respectively, after adjusting for baseline BCVA values. In eyes with residual SRF, the presence of SRF in the central subfield tended to have higher odds of obtaining BCVA ≥69 at M12 (1.81; 0.81, 4.04) and M24 (1.33; 0.59, 3.02), however, the effect was not significant.
In the HARBOR population, eyes with residual SRF at M12 and M24 had better baseline BCVA than those with resolved SRF at the same time points. Furthermore, there was no significant difference between eyes with residual SRF vs resolved SRF in attaining a BCVA of 20/40 or better (≥69 letters) at M12 and M24. As the presence of residual SRF does not appear detrimental to vision outcomes at M12 or M24, further investigation may be warranted to define the optimal SRF control needed to achieve the best long-term vision outcomes in nAMD and understand the relationship of SRF to choroidal neovascularization structure and the integrity of various retinal layers.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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