Improvement in visual outcomes in diabetic macular edema through the reduction of macular thickness fluctuations using the 0, 19 mg fluocinolone acetonide implant

This study aimed to assess the effectiveness of 0.19-mg fluocinolone acetonide intravitreal (FAc) implant to control retinal thickness fluctuations (RTF) in diabetic macular edema (DME) and its effect on best-corrected visual acuity (BCVA). The RIVER study was a multicenter, retrospective, non-interventional study analyzing data of the Retina.pt portuguese national registry in DME. Retinal thickness was assessed using the spectral domain optical coherence tomography (SD-OCT). The primary endpoint was the assessment of RTF along the follow-up, through the combined measurement of retinal thickness amplitude (RTA), retinal thickness standard deviation (RTSD), and central subfield thickness area under the curve (CST-AUC). Eyes were stratified into quartiles (Q) and median-split according to these variables. The mean follow-up time after the FAc implantation was 82 ± 26, 96 months. From baseline to last follow-up visit after the implant, mean RTA decreased from 187.6±150.4 to 151.6±126.4 µm ( p =0.1204), mean RTSD significantly reduced from 96.3±78.1 to 60.8±57.3 µm ( p =0.0032) and mean CST-AUC significantly reduced from 446 to 349 µm ( p <0.0001). BCVA significantly improved in eyes with RTA Q1, Q2, Q3 ( p <0.05); eyes with RTSD Q1, Q2, and Q3 ( p <0.05); and eyes with CST-AUC Q1, Q2, and Q3 ( p <0.05). According to the median split, eyes with RTA and RTSD < to median showed greater BCVA improvement. Retinal thickness fluctuation was significantly reduced after the Fc implant. Moreover, a lower retinal thickness variability tended to be associated with better visual outcomes.