2025 - 3 Issue

Original article

Efficacy and Safety of Intravitreal Dexamethasone Implant in Treatment-Resistant Diabetic Macular Edema: Six-month Results

Full Text links

Summary

Aims: To investigate the efficacy and safety of intravitreal Dexamethasone implant (DEX-I) therapy in the treatment of diabetic macular edema (DME) refractory to intravitreal bevacizumab (IVB).

Material and methods: This retrospective and cross-sectional study included 37 eyes of 37 patients who received 3 loading doses of IVB injections for DME with no response and underwent DEX-I implant. Best-corrected visual acuity (BCVA), intraocular pressure (IOP) measurements and central foveal thickness (CFT) measured by spectral domain optical coherence tomography (SD-OCT) were recorded and compared before DEX-I, at the first week, first, second, third and sixth months. Duration of DME, glycated hemoglobin (HbA1c) levels, DME types and lens status (phakic, pseudophakic) were also recorded.

Results: The mean age of the patients was 61.14 ±8.69 years (59.5% male, 40.5% female). 35.1% of the patients had cystoid macular edema, 64.9% had diffuse macular edema and 73 % were phakic and 27% were pseudophakic. BCVA, CFT and IOP values before DEX-I injection were 0.78 ±0.16 LogMAR, 493.73 ±107.6 µm and 13.05 ±2.59 mmHg, respectively. At 6 months after DEX-I, BCVA, CFT and IOP values were 0.64 ±0.11 LogMAR, 397.35 ±59.72 µm and 16.3 ±2.51 mmHg, respectively. In all follow-ups, there was a significant improvement in BCVA, a significant decrease in CFT and a significant increase in IOP compared to pre-injection. Ocular hypertension was observed in 0.8 % of patients and progression of cataract progression in 1% of patients after treatment.

Conclusion: DEX-I therapy is an effective and safe treatment option for DME refractory to IVB treatment.

References

  1. Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv. Ophthalmol. 2009;54(1):1-
  2. Funatsu H, Noma H, Mimura T, Eguchi S, Hori S. Association of vitreous inflammatory factors with diabetic macular edema. Ophthalmology. 2009;116(1):73-79.
  3. Funatsu H, Yamashita H, Noma H, Mimura T, Yamashita T, Hori S. Increased levels of vascular endothelial growth factor and interleukin-6 in the aqueous humor of diabetics with macular edema. Am J Ophthalmol. 2002;133(1):70-77.
  4. Early treatment diabetic retinopathy study research group: photocoagulation for diabetic macular edema: early treatment diabetic retinopathy study report no 1. Arch Ophthalmol. 1985;103:1796– 1806.
  5. Liu XD, Zhou XD, Wang Z, Shen YM. Macular laser photocoagulation with or without intravitreal triamcinolone pretreatment for diabetic macular edema: a result from five randomized controlled trials. Int J Ophthalmol. 2016;9(1):132-138.
  6. Michaelides M, Fraser-Bell S, Hamilton R, et al. Macular perfusion determined by fundus fluorescein angiography at the 4-month time point in a prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (Bolt Study): Report 1. Retina. 2010;30(5):781-786.
  7. Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012;119(4):789-801.
  8. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal Aflibercept for Diabetic Macular Edema: 100-Week Results From the VISTA and VIVID Studies. Ophthalmology. 2015;122(10):2044-2052.
  9. Yilmaz T, Weaver CD, Gallagher MJ, et al. Intravitreal triamcinolone acetonide injection for treatment of refractory diabetic macular edema: a systematic review. Ophthalmology. 2009;116(5):902-
  10. Martidis A, Duker JS, Greenberg PB, et al. Intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology. 2002;109(5):920-927.
  11. Chan CK, Mohamed S, Lee VY, Lai TY, Shanmugam MP, Lam DS. Intravitreal dexamethasone for diabetic macular edema: a pilot study. Ophthalmic Surg Lasers Imaging. 2010;41(1):26-30.
  12. Haller JA, Kuppermann BD, Blumenkranz MS, et al. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010;128(3):289-296.
  13. 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.
  14. Li H, Liu X, Zhong H, et al. Research progress on the pathogenesis of diabetic retinopathy. BMC Ophthalmol. 2023;23(1):372.
  15. Chung YR, Kim YH, Ha SJ, et al. Role of Inflammation in Classification of Diabetic Macular Edema by Optical Coherence Tomography. J Diabetes Res. 2019;2019:8164250.
  16. Noma H, Yasuda K, Shimura M. Involvement of Cytokines in the Pathogenesis of Diabetic Macular Edema. Int J Mol Sci. 2021;22(7):3427.
  17. Gillies MC, Lim LL, Campain A, et al. A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX study. Ophthalmology. 2014;121(12):2473-2481.
  18. Malclès A, Dot C, Voirin N, et al. Real-lıfe study in diabetic macular edema treated with dexamethasone implant: The Reldex Study. Retina. 2017;37(4):753-760.
  19. Maturi RK, Pollack A, Uy HS, et al. Intraocular pressure in patients with diabetic macular edema treated with dexamethasone intravitreal implant in the 3-year mead study. Retina. 2016;36(6):1143- 1152.
  20. Totan Y, Güler E, Gürağaç FB. Dexamethasone Intravitreal Implant for Chronic Diabetic Macular Edema Resistant to Intravitreal Bevacizumab Treatment. Curr Eye Res. 2016;41(1):107-113. 21 Özata K, Atum M, Çelik E, Doğan E, Alagöz G. Efficacy of intravitreal dexamethasone implant in persistent diabetic macular edema after primary treatment with intravitreal ranibizumab. J Curr Ophthalmol. 2019;31(3):281-286.
  21. Lazic R, Lukic M, Boras I, et al. Treatment of anti-vascular endothelial growth factor-resistant diabetic macular edema with dexamethasone intravitreal implant. Retina. 2014;34(4):719-724.
  22. Yucel OE, Can E, Ozturk HE, Birinci H, Sullu Y. Dexamethasone Implant in Chronic Diabetic Macular Edema Resistant to Intravitreal Ranibizumab Treatment. Ophthalmic Res. 2017;57(3):161-165.
  23. Hatz K, Ebneter A, Tuerksever C, Pruente C, Zinkernagel M. Repeated Dexamethasone Intravitreal Implant for the Treatment of Diabetic Macular Oedema Unresponsive to Anti-VEGF Therapy: Outcome and Predictive SD-OCT Features. Ophthalmologica. 2018;239(4):205-214.
  24. Zhioua I, Semoun O, Lalloum F, Souied EH. Intravitreal dexamethasone implant in patients with ranibizumab persistent diabetic macular edema. Retina. 2015;35(7):1429-1435.
  25. Nalçacı S, Akkın C, Afrashi F. Dexamethasone Implant in Patients with Diabetic Macular Edema Resistant to Anti-VEGF Therapy. Turk J Ophthalmol. 2019;49(2):73-77.
  26. Koc H, Alpay A, Ugurbas SH. Comparison of the efficacy of intravitreal Anti-VEGF versus intravitreal dexamethasone implant in treatment resistant diabetic Macular Edema. BMC Ophthalmol. 2023;23(1):97.
  27. 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.
  28. Bonfiglio V, Reibaldi M, Pizzo A, et al. Dexamethasone for unresponsive diabetic macular oedema: optical coherence tomography biomarkers. Acta Ophthalmol. 2019;97(4):e540-e544.
  29. Iglicki M, Busch C, Zur D, et al. Dexamethasone implant for diabetic macular edema in naive compared with refractory eyes: The International Retina Group Real-Life 24-Month Multicenter Study. The IRGREL-DEX Study. Retina. 2019;39(1):44-51.
  30. Boyer DS, Faber D, Gupta S, et al. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011;31(5):915-923.
  31. Akıncıoğlu D, Küçükevcilioğlu M, Durukan AH, Aykaş S, Ayyıldız Ö, Erdurman FC. Outcomes of Intravitreal Dexamethasone Implant in the Treatment of Recalcitrant Diabetic Macular Edema. Turk J Ophthalmol. 2017;47(5):274-278.
  32. Bansal P, Gupta V, Gupta A, Dogra MR, Ram J. Efficacy of Ozurdex implant in recalcitrant diabetic macular edema--a single-center experience. Int Ophthalmol. 2016;36(2):207-216.