scholarly journals Prognostic biomarkers of chronic diabetic macular edema treated with a fluocinolone acetonide intravitreal implant

2021 ◽  
Vol 10 (2) ◽  
pp. 50-58
Author(s):  
Beatriz Oliveira Lopes ◽  
Margarida Sena Brizido ◽  
Florence Aerts ◽  
Susana Morais Pina ◽  
Pedro Santana Simoes ◽  
...  

Background: This study aimed to investigate retinal imaging biomarkers, such as disorganization of the retinal inner layers (DRIL) and/or ellipsoid zone (EZ) disruption by spectral domain optical coherence tomography (SD-OCT), and functional outcomes in eyes treated with 0.2 µg/day of a fluocinolone acetonide intravitreal implant (FAc) after an insufficient response to previous treatments. Methods: This was a retrospective comparative study of 18 eyes (15 patients) with persistent and/or recurrent diabetic macular edema (DME) treated with FAc. Eyes were divided according to the number of prior intravitreal treatments: group 1 (n = 8) with less than or equal to 6 injections (early switch) and group 2 (n = 10) with > 6 injections (late switch). Outcomes included percentage of eyes with DRIL and/or EZ disruption at baseline and analysis of the best corrected visual acuity (BCVA) using ETDRS letters, central macular thickness (CMT), DRIL, and EZ disruption at the last observation. Results: Group 2 revealed a significantly higher percentage of DRIL and/or EZ disruption than group 1 (P < 0.05). At the last observation, group 1 revealed a higher percentage of eyes achieving vision stability/improvement, gaining greater than or equal to15 letters, and achieving greater than or equal to 70 letters (P > 0.05 for all comparisons). The mean BCVA gain was 8.8 and 0.7 letters for groups 1 and 2 (P = 0.397). Both groups revealed a significant mean CMT reduction (>20% reduction from the baseline value), without a significant statistical difference between them (P = 0.749). After treatment, most eyes from both groups showed resolution of DRIL and EZ disruption. Conclusions: Patients with DME presenting with a lower percentage of DRIL and/or EZ disruption at baseline had better functional outcomes, supporting the possible benefit of an early switch to FAc after insufficient response to previous treatments. Future randomized studies with a larger patient cohort are warranted to confirm our conclusions. How to cite this article: Lopes BO, Brizido MS, Aerts F, Pina SM, Simoes PS, Miranda MI. Prognostic biomarkers of chronic diabetic macular edema treated with a fluocinolone acetonide intravitreal implant. Med Hypothesis Discov Innov Ophthalmol. 2021 Summer; 10(2): 50-58. https://doi.org/10.51329/mehdiophthal1421

Author(s):  
Amr Abdelrahman ◽  
Wagiha Massoud ◽  
Ahmed Mohamed Kamal Elshafei ◽  
Mahmoud Genidy ◽  
Raafat Mohyeldeen Abdelrahman Abdallah

Abstract Background To compare the therapeutic effects of subthreshold micropulse laser (SML) versus intravitreal injection of ranibizumab in treatment of diabetic macular edema (DME) both anatomically using optical coherence tomography (OCT) and functionally using best corrected visual acuity (BCVA) and multifocal electroretinogram (mfERG). Methods his study was an interventional prospective randomized comparative study. The study included 120 eyes classified into 3 groups: Group 1 included 40 eyes of 28 patients treated by SML laser, group 2 included 40 eyes of 32 patients treated by intravitreal injection of ranibizumab, and group 3 (control group for mfERG) included 40 eyes of 20 patients with diabetes mellitus (DM) of more than 10 year duration with no signs of diabetic retinopathy (DR). BCVA measurements, OCT and mfERG were done for the cases before and after interference and were followed up for 6 months Results By the end of the follow up period, BCVA significantly improved by 31% in group 1 vs 93% in group 2 with a statistically highly significant difference between the two groups (p value < 0.001). There was also a significant decrease in central subfield thickness in both groups with more reduction in group 2 compared with group 1 (p value < 0.001). There was a significant improvement in P1 amplitude of mf-ERG in group 2 (p value < 0.002) with no significant improvement in group 1. There was a significant decrease in P1 implicit time in group 2 (p value < 0.001) while there was no significant decrease in group1. Conclusions Intravitreal injection of ranibizumab is a superior treatment modality for DME compared with SML regarding both anatomical and functional outcomes. Trial registration: This study has been approved by the local ethical committee of faculty of medicine of Minia University and retrospectively registered at the clinical trial gov. with Identifier: NCT04332133.


2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Sadık Görkem Çevik ◽  
Sami Yılmaz ◽  
Mediha Tok Çevik ◽  
Fatma Düriye Akalp ◽  
Remzi Avcı

Purpose. To compare the effectiveness of sustained-release dexamethasone (DEX) intravitreal implant in nonvitrectomized eyes and vitrectomized eyes with diabetic macular edema (DME). Methods. A retrospective review of the medical records of 40 eyes of 30 consecutive patients with diabetic macular edema who underwent intravitreal DEX implant injection. Patients were divided into 2 subgroups: 31 eyes that were nonvitrectomized (group 1) and 9 eyes that had previously undergone standard pars plana vitrectomy (group 2). The main outcome measures were BCVA and foveal thickness (FT). Results. A significant improvement was seen in BCVA in both group 1 and group 2 at the 1st, 2nd, and 6th months after treatment with DEX implant (p<0.05). In group 1, a significant reduction in FT was observed at the 1st, 2nd, and 6th months (p<0.05). In group 2, a significant reduction in FT was seen at the 1st and 2nd months (p<0.05), but the reduction rate at the 6th month after the injection was not statistically significant (p=0.06). Conclusion. DEX implant is effective for the treatment of diabetic macular edema, and the effectiveness of the drug is similar in vitrectomized and nonvitrectomized eyes.


2019 ◽  
Vol 57 (4) ◽  
pp. 469-478 ◽  
Author(s):  
Matus Rehak ◽  
Catharina Busch ◽  
Jan-Darius Unterlauft ◽  
Claudia Jochmann ◽  
Peter Wiedemann

Abstract Aims Fluocinolone acetonide (FAc) is an intravitreal corticosteroid implant approved for the second-line treatment of diabetic macular edema (DME). This study compared outcomes of patients with DME switched directly to an FAc implant, versus indirectly via dexamethasone, after anti-VEGF therapy failure. Methods This is a retrospective, single-center chart review. Patients were assigned to Group A (switched to FAc after anti-VEGF) or Group B (switched to dexamethasone and then to FAc after > 4 months). Charts were reviewed for best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and cataract development. Results Forty-nine eyes were included. BCVA increased and CMT decreased with anti-VEGF (both groups), and dexamethasone (Group B only), but regressed after stopping treatment. With FAc, BCVA increased rapidly and significantly: increases were maintained up to 36 months (P < 0.001), except at 18 and 9 months in Groups A and B, respectively. Significant CMT reductions (P < 0.001) were evident after 3 months and maintained up to 36 months in both groups. IOP increase > 21 mmHg occurred in 14 patients (nine in Group A, five in Group B): all were sufficiently treated with IOP-lowering drops. Nineteen phakic eyes (73.1%) developed cataract: seven underwent phaco-emulsification (two in Group A, five in Group B). Conclusions Similar functional and anatomical improvements occurred in FAc-treated eyes, regardless of whether they first received dexamethasone or switched directly to FAc after anti-VEGF. Safety signals were consistent with corticosteroid class effects. Early switch to FAc could benefit patients who respond insufficiently to anti-VEGF.


2017 ◽  
Vol 8 (3) ◽  
pp. 465-474 ◽  
Author(s):  
Rita Santos Gonçalves ◽  
Carla Teixeira ◽  
Pedro Coelho

Diabetic macular edema (DME) is a leading cause of blindness in the working population. Herein, we report the case of a patient with recurrent DME for about 6 years, uncontrolled by several medical and surgical treatments, that was successfully treated with a single sustained-release fluocinolone acetonide intravitreal implant in her right eye. The affected eye had presented a visual acuity of 2/10 and a central macular thickness of 488 µm prior to the injection. After treatment with the fluocinolone acetonide intravitreal implant, the patient’s right eye presented an improvement in best corrected visual acuity to 6/10 and a reduction of central macular thickness to 198 µm. These functional and anatomical results were continuous and sustained during a follow-up period of more than 12 months, and with an acceptable and manageable safety profile. These results show that fluocinolone acetonide intravitreal implantation is an effective treatment option in DME and should be considered in the DME treatment pathway.


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