Optimizing intravitreal corticosteroid therapy in diabetic macular edema: A review of clinical outcomes, safety considerations, and burden reduction
Main Article Content
Keywords
Clinical outcome, diabetic macular edema, intravitreal corticosteroids, safety profile, treatment burden
Abstract
Background: Diabetic Macular Edema (DME) is a major cause of vision impairment. A significant challenge is the management of patients who are inadequate responders to anti-vascular endothelial growth factor (VEGF) therapy and in addressing the significant treatment burden associated with frequent injections. This review aims to evaluate the efficacy, safety, and ability to reduce treatment burden offered by intravitreal corticosteroids for DME.
Methods: A narrative literature review was conducted using PubMed, Google Scholar, and ScienceDirect (2015–2025), focusing on studies reporting best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) elevation, cataract progression, injection frequency, and patient selection criteria. Inclusion emphasized randomized trials, large cohorts, and meta-analyses.
Results: DEX implants yield rapid improvements in BCVA and CMT, particularly perioperatively in cataract cases. FA implants demonstrate sustained efficacy over three years, reducing injection frequency by up to 80%. Safety concerns include predictable IOP elevation and cataractogenesis, manageable with monitoring and stratified patient selection. Corticosteroids are especially beneficial for pseudophakic, vitrectomized eyes and anti-VEGF non-responders.
Conclusion: Intravitreal corticosteroids represent a viable alternative or adjunct to anti-VEGF therapy, offering durable anatomical and functional benefits while reducing treatment burden. Strategic patient selection and proactive safety monitoring are essential to optimize outcomes.
References
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33. Gabrielle PH, Mehta H, Barthelmes D, Daien V, Nguyen V, Gillies MC, et al. From randomised controlled trials to real-world data: Clinical evidence to guide management of diabetic macular oedema. Prog Retin Eye Res. 2023 Nov;97:101219. DOI: 10.1016/j.preteyeres.2023.101219
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35. Pessoa B, Coelho J, Correia N, Ferreira N, Beirão M, Meireles A. Fluocinolone Acetonide Intravitreal Implant 190 μg (ILUVIEN®) in Vitrectomized versus Nonvitrectomized Eyes for the Treatment of Chronic Diabetic Macular Edema. Ophthalmic Res. 2018;59(2):68–75. DOI: 10.1159/000484091
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2. Gao L, Zhao X, Jiao L, Tang L. Intravitreal corticosteroids for diabetic macular edema: a network meta-analysis of randomized controlled trials. Eye and Vision. 2021 Dec 11;8(1):35. DOI: 10.1186/s40662-021-00261-3
3. Cheng Z, Liu X. Comparing the efficacy of glucocorticoids and anti-VEGF in treating diabetic macular edema: systematic review and comprehensive analysis. Front Endocrinol (Lausanne). 2024 Mar 22;15. DOI: 10.3389/fendo.2024.1342530
4. Panozzo GA, Gusson E, Panozzo G, Dalla Mura G. Dexamethasone Intravitreal Implant at the Time of Cataract Surgery in Eyes with Diabetic Macular Edema. Eur J Ophthalmol. 2017 Jun 26;27(4):433–7. DOI: 10.5301/ejo.5000920
5. Furino C, Boscia F, Niro A, Giancipoli E, Grassi MO, D’amico Ricci G, et al. Combined Phacoemulsification and Intravitreal Dexamethasone Implant (Ozurdex®) in Diabetic Patients with Coexisting Cataract and Diabetic Macular Edema. J Ophthalmol. 2017;2017:1–7. DOI: 10.1155/2017/4896036
6. Kabanarou SA, Xirou T, Boutouri E, Gkizis I, Vasilias D, Bontzos G, et al. Pre-operative intravitreal dexamethasone implant in patients with refractory diabetic macular edema undergoing cataract surgery. Sci Rep. 2020 Mar 26;10(1):5534. DOI: 10.1038/s41598-020-62561-3
7. Herold TR, Liegl R, Koenig S, Almarzooqi A, Priglinger SG, Wolf A. Scleral Fixation of the Fluocinolone Acetonide Implant in Eyes with Severe Iris–Lens Diaphragm Disruption and Recalcitrant CME: The Fluocinolone-Loop-Anchoring Technique (FLAT). Ophthalmol Ther. 2020 Mar 13;9(1):175–9. DOI: 10.1007/s40123-020-00232-2
8. Hsia NY, Lin CJ, Chen HS, Chang CH, Bair H, Lai CT, et al. Short-Term Outcomes of Refractory Diabetic Macular Edema Switch From Ranibizumab to Dexamethasone Implant and the Influential Factors: A Retrospective Real World Experience. Front Med (Lausanne). 2021 Apr 30;8. DOI: 10.3389/fmed.2021.649979
9. Chakraborty S, Ganguly S, Sheth J. Role of Intravitreal Dexamethasone Implant in the Management of Treatment-Naive Diabetic Macular Edema: A Pre-Cataract Surgical Approach for Patients with Systemic Contraindications to Anti-VEGF Therapy. Clinical Ophthalmology. 2024 Jan;Volume 18:227–33. DOI: 10.2147/OPTH.S449250
10. Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, et al. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29. DOI: 10.1001/jamaophthalmol.2017.4914
11. Ratra D, Sharma U, Dalan D. Efficacy and safety of intravitreal dexamethasone implant in treatment naïve eyes with diabetic macular edema: Real world experience. Eur J Ophthalmol. 2021 Jul 10;31(4):1899–906. DOI: 10.1177/1120672120949761
12. Cheng Z, Liu X. Comparing the efficacy of glucocorticoids and anti-VEGF in treating diabetic macular edema: systematic review and comprehensive analysis. Front Endocrinol (Lausanne). 2024 Mar 22;15. DOI: 10.3389/fendo.2024.1342530
13. Wolfrum P, Böhm EW, Lorenz K, Stoffelns B, Pfeiffer N, Korb CA. Short-Term Clinical Outcomes of Patients with Diabetic Macular Edema Following a Therapy Switch to Faricimab. J Clin Med. 2024 Aug 1;13(15):4508. DOI: 10.3390/jcm13154508
14. Taloni A, Coco G, Rastelli D, Buffon G, Scorcia V, Giannaccare G. Safety and Efficacy of Dexamethasone Intravitreal Implant Given Either First-Line or Second-Line in Diabetic Macular Edema. Patient Prefer Adherence. 2023;17:3307–29. DOI: 10.2147/PPA.S427209
15. Chauhan MZ, Rather PA, Samarah SM, Elhusseiny AM, Sallam AB. Current and Novel Therapeutic Approaches for Treatment of Diabetic Macular Edema. Cells. 2022 Jun 17;11(12):1950. DOI: 10.3390/cells11121950
16. Celik N. Complications of dexamethasone implants: risk factors, prevention, and clinical management. Int J Ophthalmol. 2020 Oct 18;13(10):1612–20. DOI: 10.18240/ijo.2020.10.16
17. Mushtaq Y, Mushtaq MM, Gatzioufas Z, Ripa M, Motta L, Panos GD. Intravitreal Fluocinolone Acetonide Implant (ILUVIEN®) for the Treatment of Retinal Conditions. A Review of Clinical Studies. Drug Des Devel Ther. 2023;17:961–75. DOI: 10.2147/DDDT.S403259
18. Neves P, Ornelas M, Matias I, Rodrigues J, Santos M, Dutra-Medeiros M, et al. Dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema: real-world data versus clinical trials outcomes. Int J Ophthalmol. 2021;14(10):1571–80. DOI: 10.18240/ijo.2021.10.15
19. Ruiz-Moreno JM, Adán A, Lafuente M, Asencio Durán M, Arias Barquet L, García Layana A, et al. Effectiveness and safety of fluocinolone acetonide intravitreal implant in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT): a prospective, non-randomized, and multicenter study. Int Ophthalmol. 2023 Dec;43(12):4639–49. DOI: 10.1007/s10792-023-02864-2
20. Sejournet L, Mathis T, Vermot-Desroches V, Serra R, Fenniri I, Denis P, et al. Efficacy and Safety of Fluocinolone Acetonide Implant in Diabetic Macular Edema: Practical Guidelines from Reference Center. Pharmaceutics. 2024 Sep 7;16(9). DOI: 10.3390/pharmaceutics16091183
21. Eaton A, Koh SS, Jimenez J, Riemann CD. The USER Study: A Chart Review of Patients Receiving a 0.2 µg/day Fluocinolone Acetonide Implant for Diabetic Macular Edema. Ophthalmol Ther. 2019 Mar 17;8(1):51–62. DOI: 10.1007/s40123-018-0155-5
22. Mathis T, Papegaey M, Ricard C, Rezkallah A, Matonti F, Sudhalkar A, et al. Efficacy and Safety of Intravitreal Fluocinolone Acetonide Implant for Chronic Diabetic Macular Edema Previously Treated in Real-Life Practice: The REALFAc Study. Pharmaceutics. 2022 Mar 28;14(4):723. DOI: 10.3390/pharmaceutics14040723
23. Adams OE, Schechet SA, Hariprasad SM. Discontinuous to continuous therapy for persistent diabetic macular edema leads to reduction in treatment frequency. Eur J Ophthalmol. 2021 Mar 21;31(2):612–9. DOI: 10.1177/1120672120901691
24. Pessoa B, Coelho J, Correia N, Ferreira N, Beirão M, Meireles A. Fluocinolone Acetonide Intravitreal Implant 190 μg (ILUVIEN®) in Vitrectomized versus Nonvitrectomized Eyes for the Treatment of Chronic Diabetic Macular Edema. Ophthalmic Res. 2018;59(2):68–75. DOI: 10.1159/000484091
25. Parrish RK, Traverso CE, Green K, Danis RP. Quantitative Assessment of Optic Nerve Changes in Patients With Diabetic Macular Edema Treated With Fluocinolone Acetonide Vitreous Implants. Ophthalmic Surg Lasers Imaging Retina. 2016 May;47(5):418–25. DOI: 10.3928/23258160-20160419-04
26. Ong SS, Walter SD, Chen X, Thomas AS, Finn AP, Fekrat S. Bilateral Intravitreal 0.19-Mg Fluocinolone Acetonide Implant For Persistent Nondiabetic Cystoid Macular Edema After Vitrectomy. Retin Cases Brief Rep. 2021 May;15(3):261–5. DOI: 10.1097/ICB.0000000000000779
27. Figueira J, Henriques J, Amaro M, Rosas V, Alves D, Cunha-Vaz J. A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND). Ophthalmic Res. 2017;57(3):166–72. DOI: 10.1159/000455235
28. Lautredou CC, Hardin JS, Chancellor JR, Uwaydat SH, Ellabban AA, Sallam AB. Repeat Intravitreal Dexamethasone Implant for Refractory Cystoid Macular Edema in Syphilitic Uveitis. Case Rep Ophthalmol Med. 2018;2018:1–3. DOI: 10.1155/2018/7419823
29. Schechet SA, Adams OE, Eichenbaum DA, Hariprasad SM. Macular thickness amplitude changes when switching from discontinuous to continuous therapy for diabetic macular oedema. BMJ Open Ophthalmol. 2019 Mar 29;4(1):e000271. DOI: 10.1136/bmjophth-2019-000271
30. Downey L, Acharya N, Devonport H, Gale R, Habib M, Manjunath V, et al. Treatment choices for diabetic macular oedema: a guideline for when to consider an intravitreal corticosteroid, including adaptations for the COVID-19 era. BMJ Open Ophthalmol. 2021 Apr;6(1):e000696. DOI: 10.1136/bmjophth-2020-000696
31. Massin P, Erginay A, Dupas B, Couturier A, Tadayoni R. Efficacy and safety of sustained-delivery fluocinolone acetonide intravitreal implant in patients with chronic diabetic macular edema insufficiently responsive to available therapies: a real-life study. Clinical Ophthalmology. 2016 Jul;Volume 10:1257–64. DOI: 10.2147/OPTH.S105385
32. Augustin AJ, Kuppermann BD, Lanzetta P, Loewenstein A, Li XY, Cui H, et al. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study. BMC Ophthalmol. 2015 Dec 30;15(1):150. DOI: 10.1186/s12886-015-0148-2
33. Gabrielle PH, Mehta H, Barthelmes D, Daien V, Nguyen V, Gillies MC, et al. From randomised controlled trials to real-world data: Clinical evidence to guide management of diabetic macular oedema. Prog Retin Eye Res. 2023 Nov;97:101219. DOI: 10.1016/j.preteyeres.2023.101219
34. Bandello F, Toni D, Porta M, Varano M. Diabetic retinopathy, diabetic macular edema, and cardiovascular risk: the importance of a long-term perspective and a multidisciplinary approach to optimal intravitreal therapy. Acta Diabetol. 2020 May 20;57(5):513–26. DOI: 10.1007/s00592-019-01453-z
35. Pessoa B, Coelho J, Correia N, Ferreira N, Beirão M, Meireles A. Fluocinolone Acetonide Intravitreal Implant 190 μg (ILUVIEN®) in Vitrectomized versus Nonvitrectomized Eyes for the Treatment of Chronic Diabetic Macular Edema. Ophthalmic Res. 2018;59(2):68–75. DOI: 10.1159/000484091
36. Çevik SG, Yılmaz S, Çevik MT, Akalp FD, Avcı R. Comparison of the Effect of Intravitreal Dexamethasone Implant in Vitrectomized and Nonvitrectomized Eyes for the Treatment of Diabetic Macular Edema. J Ophthalmol. 2018;2018:1–8. DOI: 10.1155/2018/1757494
37. Regillo CD, Callanan DG, Do D V., Fine HF, Holekamp NM, Kuppermann BD, Singer MA, Singh RP. Use of Corticosteroids in the Treatment of Patients With Diabetic Macular Edema Who Have a Suboptimal Response to Anti-VEGF: Recommendations of an Expert Panel. Ophthalmic Surg Lasers Imaging Retina. 2017 Apr;48(4):291–301. DOI: 0.3928/23258160-20170329-03
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