Author: Diogo Filipe Maleita (Portugal)
Co-authors: Diogo Maleita, Rita Serras-Pereira, Edgar Lopes, Bruna Cunha, Ricardo Figueiredo, Miguel Marques
The first endpoint of this study aimed to evaluate long-term visual, anatomic and safety outcomes in patients with diabetic macular edema (DME) treated with fluocinolone acetonide intravitreal implant [FAc] in a real-world clinical setting. The second endpoint intended to investigate the change of OCT prognostic and predictive biomarkers.
Retrospective, single center analysis conducted at the Ophthalmology Department, Centro Hospitalar Universitário Lisboa Central - Lisbon, Portugal.
Retrospective data collection and analysis of consecutive 13 eyes (11 patients) treated with ILUVIEN® (190µg FAc intravitreal implant) for DME insufficiently responsive to previous treatments (persistent/recurrent DME despite treatment). Standard measurements included: visual acuity (BCVA; ETDRS letter score), central macular thickness (CMT; µm), macular volume (MV; mm3), intraocular pressure (IOP; mmHg), IOP related events. All parameters were assessed at baseline, and months 1,3 and 6, and then semesterly afterward. The mean follow-up period was 31.85±6.19 months (mean±standard deviation) (range, 18 to 36 months) and all results are reported at the last observation. Prior treatments were recorded. Additional assessments were performed to determine the percentual change of specific retinal OCT biomarkers (disorganization of the retinal inner layers [DRIL], ellipsoid zone [EZ] disruption, subfoveal neuroretinal detachment [SND], number of hyperreflective foci [HRF] >30 and intraretinal cysts graduation [severe, moderate, mild and absent]) at baseline, 12 months, 24 months and 36 months post-FAc. Imaging biomarkers were assessed by SD-OCT, based on the 1-mm diameter central region. Regarding statistical analysis, T-test and Fisher's exact Chi-squared test were performed using SPSS (version 25.0); statistical significance was taken as p-value<0.05.
At baseline, patients had a median(±SD) age of 73±7.2 years and had been diagnosed with DME for 5±1.54 years. Seventy-seven percent of eyes were pseudophakic and 69% were male. All eyes had received laser and anti-VEGF intravitreal treatment before FAc implant, 85% were treated with short-acting corticosteroid intravitreal therapy and none of the eyes had prior vitrectomy. The baseline median(±SD) BCVA, CRT, MV and IOP were 35±19.91 ETDRS letters, 691±207.88µm, 12.72±2.74mm3 and 12.72±2.72mmHg, respectively. At last observation, visual acuity stabilized/improved in 85% of eyes (median(±SD) BCVA of 35±23.12 ETDRS letters [p=0.12]), anatomical reduction of CRT and MV in -435µm (>35% reduction from baseline [p=0.08]) and -3.4 mm3 [p=0.04], respectively. IOP increased slightly to 15mmHg [p=0.97] and 38% of eyes were being treated with IOP-lowering medication. Thirty-one percent of eyes received supplemental DME treatment. In terms of OCT biomarkers, at baseline, 92%, 85%, 8% and 77% of eyes had DRIL, EZ disruption, SND and HRF>30, respectively. 54%, 39%, 8% and 0% had severe, moderate, mild and absent intraretinal cysts. All the imaging biomarkers improved during treatment.
This real-world study examines the FAc implant effectiveness as a long-term option in treating DME that persists or recurs despite treatment. The high rate of poor functional prognostic OCT biomarkers before FAc implant led to no significant gains in visual acuity in most patients. Despite this bad baseline prognosis, 85% of eyes had their visual acuity stabilized or improved during the follow-up period. Reduction of the central macular thickness by >35% from baseline and an improvement of imaging biomarkers during the treatment was also observed in this cohort.