165
Views
2
CrossRef citations to date
0
Altmetric
Original Research

A Real-World Study of Dexamethasone Implant in Treatment-Naïve Patients with Diabetic Macular Edema: Efficacy and Correlation Between Inflammatory Biomarkers and Treatment Outcome

ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon
Pages 2657-2665 | Published online: 15 Sep 2020

References

  • Alkuraya H, Kangave D, Abu El-Asrar AM. The correlation between optical coherence tomographic features and severity of retinopathy, macular thickness and visual acuity in diabetic macular edema. Int Ophthalmol. 2005;26:93–99. doi:10.1007/s10792-006-9007-8
  • Romero-Aroca P. Targeting the pathophysiology of diabetic macular edema. Diabetes Care. 2010;33:2484–2485. doi:10.2337/dc10-1580
  • Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009;54:1–32. doi:10.1016/j.survophthal.2008.10.001
  • Johnson MW. Etiology and treatment of macular edema. Am J Ophthalmol. 2009;147(11–21):e1. doi:10.1016/j.ajo.2008.07.024
  • Vujosevic S, Simo R. Local and systemic inflammatory biomarkers of diabetic retinopathy: an integrative approach. Invest Ophthalmol Vis Sci. 2017;58:BIO68–BIO75. doi:10.1167/iovs.17-21769
  • Midena E, Pilotto E, Bini S. Hyperreflective intraretinal foci as an OCT biomarker of retinal inflammation in diabetic macular edema. Invest Ophthalmol Vis Sci. 2018;59:5366. doi:10.1167/iovs.18-25611
  • Otani T, Kishi S, Maruyama Y. Patterns of diabetic macular edema with optical coherence tomography. Am J Ophthalmol. 1999;127:688–693. doi:10.1016/S0002-9394(99)00033-1
  • Gaucher D, Sebah C, Erginay A, et al. Optical coherence tomography features during the evolution of serous retinal detachment in patients with diabetic macular edema. Am J Ophthalmol. 2008;145:289–296. doi:10.1016/j.ajo.2007.09.029
  • Nagaoka T, Kitaya N, Sugawara R, et al. Alteration of choroidal circulation in the foveal region in patients with type 2 diabetes. Br J Ophthalmol. 2004;88:1060–1063. doi:10.1136/bjo.2003.035345
  • Seo KH, Yu SY, Kim M, Kwak HW. Visual and morphologic outcomes of intravitreal ranibizumab for diabetic macular edema based on optical coherence tomography patterns. Retina. 2016;36:588–595. doi:10.1097/IAE.0000000000000770
  • Sonoda S, Sakamoto T, Yamashita T, Shirasawa M, Otsuka H, Sonoda Y. Retinal morphologic changes and concentrations of cytokines in eyes with diabetic macular edema. Retina. 2014;34:741–748. doi:10.1097/IAE.0b013e3182a48917
  • Brito P, Costa J, Gomes N, Costa S, Correia-Pinto J, Silva R. Serological inflammatory factors as biomarkers for anatomic response in diabetic macular edema treated with anti-VEGF. J Diabetes Complications. 2018;32:643–649. doi:10.1016/j.jdiacomp.2018.05.006
  • Sun JK, Lin MM, Lammer J, et al. Disorganization of the retinal inner layers as a predictor of visual acuity in eyes with center-involved diabetic macular edema. JAMA Ophthalmol. 2014;132:1309–1316. doi:10.1001/jamaophthalmol.2014.2350
  • Garcia-Layana A, Figueroa MS, Arias L, et al. Clinical decision-making when treating diabetic macular edema patients with dexamethasone intravitreal implants. Ophthalmologica. 2018;240:61–72. doi:10.1159/000486800
  • Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118:615–625. doi:10.1016/j.ophtha.2011.01.031
  • Tranos PG, Wickremasinghe SS, Stangos NT, Topouzis F, Tsinopoulos I, Pavesio CE. Macular edema. Surv Ophthalmol. 2004;49:470–490. doi:10.1016/S0039-6257(04)00109-2
  • Augustin AJ. Upcoming therapeutic advances in diabetic macular edema: an intravitreal dexamethasone drug delivery system. Expert Opin Drug Deliv. 2011;8:271–279. doi:10.1517/17425247.2011.548802
  • Bucolo C, Gozzo L, Longo L, Mansueto S, Vitale DC, Drago F. Long-term efficacy and safety profile of multiple injections of intravitreal dexamethasone implant to manage diabetic macular edema: a systematic review of real-world studies. J Pharmacol Sci. 2018;138:219–232. doi:10.1016/j.jphs.2018.11.001
  • Yang Y, Bailey C, Loewenstein A, Massin P. Intravitreal corticosteroids in diabetic macular edema: pharmacokinetic considerations. Retina. 2015;35:2440–2449. doi:10.1097/IAE.0000000000000726
  • European Medicines Agency (EMA) 2015. OZURDEX (dexamethasone) 700 micrograms intravitreal implant in applicator: summary of product characteristics. Available from: https://www.ema.europa.eu/. Accessed March 23, 2020.
  • U. S. Food & Drug Administration (FDA) 2014. OZURDEX (dexamethasone intravitreal implant). Highlights of prescribing information. Available from: https://www.acessdata.fda.gov. Accessed March 23, 2020.
  • 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;121:1904–1914. doi:10.1016/j.ophtha.2014.04.024
  • Panozzo G, Gusson E, Panozzo G, Dalla Mura G. Dexamethasone intravitreal implant for diabetic macular edema: indications for a PRN regimen of treatment. Eur J Ophthalmol. 2015;25:347–351. doi:10.5301/ejo.5000563
  • Iglicki M, Zur D, Busch C, Okada M, Loewenstein A. Progression of diabetic retinopathy severity after treatment with dexamethasone implant: a 24-month cohort study the ‘DR-Pro-DEX Study’. Acta Diabetol. 2018;55:541–547. doi:10.1007/s00592-018-1117-z
  • Mello Filho P, Andrade G, Maia A, et al. Effectiveness and safety of intravitreal dexamethasone implant (Ozurdex) in patients with diabetic macular edema: a real-world experience. Ophthalmologica. 2019;241:9–16. doi:10.1159/000492132
  • Schreur V, Altay L, van Asten F, et al. Hyperreflective foci on optical coherence tomography associate with treatment outcome for anti-VEGF in patients with diabetic macular edema. PLoS One. 2018;13:e0206482. doi:10.1371/journal.pone.0206482
  • Murakami T, Yoshimura N. Structural changes in individual retinal layers in diabetic macular edema. J Diabetes Res. 2013;2013:920713. doi:10.1155/2013/920713
  • Wu PC, Lai CH, Chen CL, Kuo CN. Optical coherence tomographic patterns in diabetic macula edema can predict the effects of intravitreal bevacizumab injection as primary treatment. J Ocul Pharmacol Ther. 2012;28:59–64. doi:10.1089/jop.2011.0070
  • Zur D, Iglicki M, Busch C, et al. OCT biomarkers as functional outcome predictors in diabetic macular edema treated with dexamethasone implant. Ophthalmology. 2018;125:267–275. doi:10.1016/j.ophtha.2017.08.031
  • Novais EA, Roisman L, de Oliveira PR, et al. Optical coherence tomography angiography of chorioretinal diseases. Ophthalmic Surg Lasers Imaging Retina. 2016;47:848–861. doi:10.3928/23258160-20160901-09
  • Vujosevic S, Torresin T, Bini S, et al. Imaging retinal inflammatory biomarkers after intravitreal steroid and anti-VEGF treatment in diabetic macular oedema. Acta Ophthalmol. 2016.
  • Coscas G, De Benedetto U, Coscas F, et al. Hyperreflective dots: a new spectral-domain optical coherence tomography entity for follow-up and prognosis in exudative age-related macular degeneration. Ophthalmologica. 2013;229:32–37. doi:10.1159/000342159
  • Liu S, Wang D, Chen F, Zhang X. Hyperreflective foci in OCT image as a biomarker of poor prognosis in diabetic macular edema patients treating with Conbercept in China. BMC Ophthalmol. 2019;19:157. doi:10.1186/s12886-019-1168-0
  • Fonollosa A, Zarranz-Ventura J, Valverde A, et al. Predictive capacity of baseline hyperreflective dots on the intravitreal dexamethasone implant (Ozurdex(R)) outcomes in diabetic macular edema: a multicenter study. Graefes Arch Clin Exp Ophthalmol. 2019;257:2381–2390. doi:10.1007/s00417-019-04446-4
  • Vujosevic S, Berton M, Bini S, Casciano M, Cavarzeran F, Midena E. Hyperreflective retinal spots and visual function after anti-vascular endothelial growth factor treatment in center-involving diabetic macular edema. Retina. 2016;36:1298–1308. doi:10.1097/IAE.0000000000000912
  • Ascaso FJ, Huerva V, Grzybowski A. The role of inflammation in the pathogenesis of macular edema secondary to retinal vascular diseases. Mediators Inflamm. 2014;2014:432685. doi:10.1155/2014/432685
  • Zur D, Iglicki M, Loewenstein A. The role of steroids in the management of diabetic macular edema. Ophthalmic Res. 2019;62:231–236. doi:10.1159/000499540
  • 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:e217–e23. doi:10.1111/aos.14230
  • Keane PA, Sadda SR. Predicting visual outcomes for macular disease using optical coherence tomography. Saudi J Ophthalmol. 2011;25:145–158. doi:10.1016/j.sjopt.2011.01.003
  • Roh MI, Kim JH, Kwon OW. Features of optical coherence tomography are predictive of visual outcomes after intravitreal bevacizumab injection for diabetic macular edema. Ophthalmologica. 2010;224:374–380. doi:10.1159/000313820
  • Vujosevic S, Torresin T, Berton M, Bini S, Convento E, Midena E. Diabetic macular edema with and without subfoveal neuroretinal detachment: two different morphologic and functional entities. Am J Ophthalmol. 2017;181:149–155. doi:10.1016/j.ajo.2017.06.026
  • Hollo G, Aung T, Cantor LB, Aihara M. Cystoid macular edema related to cataract surgery and topical prostaglandin analogs: mechanism, diagnosis, and management. Surv Ophthalmol. 2020;65:496–512. doi:10.1016/j.survophthal.2020.02.004
  • Escobar-Barranco JJ, Pina-Marin B, Fernandez-Bonet M. Dexamethasone implants in patients with naive or refractory diffuse diabetic macular edema. Ophthalmologica. 2015;233:176–185. doi:10.1159/000371770
  • Guigou S, Hajjar C, Parrat E, et al. [Multicenter Ozurdex(R) assessment for diabetic macular edema: MOZART study]. J Fr Ophtalmol. 2014;37:480–485. doi:10.1016/j.jfo.2014.03.001. French.
  • 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;39:44–51. doi:10.1097/IAE.0000000000002196
  • Malcles A, Dot C, Voirin N, et al. Real-life study in diabetic macular edema treated with dexamethasone implant: the Reldex Study. Retina. 2017;37:753–760. doi:10.1097/IAE.0000000000001234
  • Matonti F, Guigou S, Pommier S, et al. Dexamethasone implants in patients with naive diabetic macular edema. Ophthalmologica. 2016;235:244. doi:10.1159/000446296
  • Choi MY, Jee D, Kwon JW. Characteristics of diabetic macular edema patients refractory to anti-VEGF treatments and a dexamethasone implant. PLoS One. 2019;14:e0222364. doi:10.1371/journal.pone.0222364
  • Sarao V, Veritti D, Furino C, et al. Dexamethasone implant with fixed or individualized regimen in the treatment of diabetic macular oedema: six-month outcomes of the UDBASA study. Acta Ophthalmol. 2017;95:e255–e60. doi:10.1111/aos.13395
  • 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;27:433–437. doi:10.5301/ejo.5000920
  • Do DV, Nguyen QD, Boyer D, et al. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012;119:1658–1665. doi:10.1016/j.ophtha.2012.02.010
  • Campos A, Campos EJ, do Carmo A, et al. Evaluation of markers of outcome in real-world treatment of diabetic macular edema. Eye Vis (Lond). 2018;5:27. doi:10.1186/s40662-018-0119-9