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Intravitreal Dexamethasone Implant in the Treatment of Diabetic Macular Edema Focusing


Authors: Tomáš Mudroch 1,2;  Michal Hrevuš 1,2;  Marta Karhanová 1,2;  Jiří Řehák 1,2;  Klára Marešová 1,2
Authors‘ workplace: Fakultní nemocnice Olomouc, Oční klinika 1;  Univerzita Palackého v Olomouci, Lékařská fakulta, Oční klinika 2
Published in: Čes. a slov. Oftal., 80, 2024, No. Ahead of print, p. 1-8
Category: Original Article
doi: https://doi.org/10.31348/2024/29

Overview

Objective: The aim of this study was to evaluate the outcomes of Ozurdex® (DEX) implant in patients with diabetic macular edema (DME) in real-world

clinical practice, and to determine the correlation between known OCT biomarkers and the effect of treatment.

Material and Methods: This retrospective study included 42 eyes of 33 patients (16 women, 17 men) treated with DEX at the Department of Ophthalmology, Faculty of Medicine and Dentistry of Palacký University and University Hospital Olomouc for DME indication between 2020 and 2023. Follow-up examinations were conducted at 1, 3, and 6 months after the first DEX application. The main assessed parameters were: best-corrected visual acuity (BCVA), intraocular pressure (IOP), central retinal thickness (CRT), OCT biomarkers. The results were subsequently statistically evaluated.

Results: At the first follow-up after DEX application, there was an average decrease in CRT of 186 ±146µm and a gain of 3 ±7 letters. Positive morphological and functional responses were observed in 39 eyes (92.9%) and 23 eyes (54.8%) respectively. The disorganization of retinal inner layers (DRIL) biomarker was initially present in 41 eyes (97.6%), with reduction or disappearance observed in 13 eyes (31%) post-application. Eyes with ellipsoid zone disruption (EZ disruption) had an average initial BCVA of 49.6 letters, compared to 57.8 letters in the group without this biomarker. The mean gain in BCVA was +8.7 letters in treatment-naive eyes and +2.1 letters in previously treated eyes. Chronic DME was less frequent in treatment-naive (n = 1, 14.3%) compared to previously treated eyes (n = 28, 84.8%). All these results were statistically significant (p < 0.05). An increase in IOP post-DEX application occurred in 9 patients (21.4%).

Conclusion: Our results confirm DEX as a safe and effective treatment option for DME. Treatment-naive patients achieved better functional outcomes. We confirmed ellipsoid zone disruption (EZ disruption) as a negative biomarker. Additionally, we demonstrated the capacity of DEX to reduce disorganization of the retinal inner layers (DRIL).

Keywords:

diabetic macular edema – dexamethasone – OCT biomarkers – Ozurdex


Sources
  1. Munk MR, Somfai GM, de Smet MD, et al. The Role of Intravitreal Corticosteroids in the Treatment of DME: Predictive OCT Biomarkers. Int J Mol Sci. 2022;23(14):7585. Published 2022 Jul 8. doi:10.3390/ijms23147585
  2. Ernest J, Němčanský J, Vysloužilová D, Veith M, Studnička J, Němec P. Diabetic Macular Edema – Diagnostics and Treatment Guidelines. Cesk Slov Oftalmol. 2023;79(5):225-235. doi:10.31348/2023/27
  3. Němčanský J, Studnička J, Vysloužilová D, Ernest J, Němec P. Diabetic Retinopathy and Diabetic Macular Edema – Screening. Cesk Slov Oftalmol. 2023;79(5):250-255. doi:10.31348/2023/29
  4. Studnička J, Němčanský J, Vysloužilová D, Ernest J, Němec P. Diabetic Retinopathy – Diagnostics and Treatment Guidelines. Cesk Slov Oftalmol. 2023;79(5):238-247. doi:10.31348/2023/28
  1. Summary of Product Characteristics of OzurdexR [Internet]. Date of revision: 20.7.2022. [cited 2024 Feb 28]. Avaliable from: https:// www.ema.europa.eu/cs/documents/product-information/ozur-  dex-epar-product-information_cs.pdf
  2. Visioli G, Alisi L, Mastrogiuseppe E, et al. OCT biomarkers as predictors of visual improvement in diabetic macular edema eyes receiving dexamethasone implants. Int J Retina Vitreous. 2023;9(1):35. Published 2023 Jun 14. doi:10.1186/s40942-023-00473-w
  3. Dugel PU, Bandello F, Loewenstein A. Dexamethasone intravitreal implant in the treatment of diabetic macular edema. Clin Ophthalmol. 2015;9:1321-1335. doi:10.2147/OPTH.S79948
  4. Vujosevic S, Toma C, Villani E, et al. Diabetic macular edema with neuroretinal detachment: OCT and OCT-angiography biomarkers of treatment response to anti-VEGF and steroids. Acta Diabetol. 2020;57(3):287-296. doi:10.1007/s00592-019-01424-4
  5. Chatziralli I, Theodossiadis P, Parikakis E, et al. Dexamethasone Intravitreal Implant in Diabetic Macular Edema: Real-Life Data from a Prospective Study and Predictive Factors for Visual Outcome. Diabetes Ther. 2017;8(6):1393-1404. doi:10.1007/s13300017-0332-x
  6. Neves P, Ornelas M, Matias I, et al. Dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema: real-world data versus clinical trials outcomes. Int J Ophthalmol. 2021;14(10):1571-1580. doi:10.18240/ijo.2021.10.15
  7. Muftuoglu IK, Mendoza N, Gaber R, Alam M, You Q, Freeman WR. Integrity of outer retinal layers after resolution of central involved diabetic macular edema. Retina. 2017;37(11):2015-2024. doi:10.1097/IAE.0000000000001459
  8. Rangaraju L, Jiang X, McAnany JJ, et al. Association between Visual Acuity and Retinal Layer Metrics in Diabetics with and without Macular Edema. J Ophthalmol. 2018;2018:1089043. Published 2018 Oct 3. doi:10.1155/2018/1089043
  9. Huang YT, Chang YC, Meng PP, et al. Optical Coherence Tomography Biomarkers in Predicting Treatment Outcomes of Diabetic Macular Edema After Dexamethasone Implants. Front Med (Lausanne). 2022;9:852022. Published 2022 Jun 9. doi:10.3389/ fmed.2022.852022
  10. Zur D, Iglicki M, Sala-Puigdollers A, et al. Disorganization of retinal inner layers as a biomarker in patients with diabetic macular oedema treated with dexamethasone implant. Acta Ophthalmol. 2020;98(2):e217-e223. doi:10.1111/aos.14230
  11. Reznicek L, Cserhati S, Seidensticker F, et al. Functional and morphological changes in diabetic macular edema over the course of anti-vascular endothelial growth factor treatment. Acta Ophthalmol. 2013;91(7):e529-e536. doi:10.1111/aos.12153
  12. Zur D, Iglicki M, Busch C, et al. OCT Biomarkers as Functional Outcome Predictors in Diabetic Macular Edema Treated with Dexamethasone Implant. Ophthalmology. 2018;125(2):267-275. doi:10.1016/j.ophtha.2017.08.031
  13. Rübsam A, Wernecke L, Rau S, et al. Behavior of SD-OCT Detectable Hyperreflective Foci in Diabetic Macular Edema Patients after Therapy with Anti-VEGF Agents and Dexamethasone Implants. J Diabetes Res. 2021;2021:8820216. Published 2021 Apr 13. doi:10.1155/2021/8820216
  14. Boyer DS, Yoon YH, Belfort R Jr, et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014;121(10):1904-1914. doi:10.1016/j.ophtha.2014.04
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