Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region

References

• Sabanayagam C, Yip W, Ting DS, Tan G, Wong TY. Emerging trends in the epidemiology of diabetic retinopathy. Ophthalmic Epidemiol. 2016;23(4):209–222. doi:10.1080/09286586.2016.1193618
   PubMed Web of Science ®Google Scholar
• Ogurtsova K, da Rocha Fernandes JD, Huang Y, et al. IDF Diabetes Atlas: global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017;128:40–50. doi:10.1016/j.diabres.2017.03.024
   PubMed Web of Science ®Google Scholar
• Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis. 2015;2(1):17. doi:10.1186/s40662-015-0026-2
   PubMedGoogle Scholar
• Yau JW, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35(3):556–564. doi:10.2337/dc11-1909
   PubMed Web of Science ®Google Scholar
• Xu Y, Wang L, He J, et al. Prevalence and control of diabetes in Chinese adults. JAMA. 2013;310(9):948–959. doi:10.1001/jama.2013.168118
   PubMed Web of Science ®Google Scholar
• Cui J, Ren JP, Chen DN, et al. Prevalence and associated factors of diabetic retinopathy in Beijing, China: a cross-sectional study. BMJ Open. 2017;7(8):e015473. doi:10.1136/bmjopen-2016-015473
   Web of Science ®Google Scholar
• Wang N, Xu X, Zou H, Zhu J, Wang W, Ho PC. The status of diabetic retinopathy and diabetic macular edema in patients with type 2 diabetes: a survey from Beixinjing district of Shanghai city in China. Ophthalmologica. 2008;222(1):32–36. doi:10.1159/000109276
   Web of Science ®Google Scholar
• Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis. Cochrane Database Syst Rev. 2018;10(10):Cd007419.
   Google Scholar
• Regillo CD, Callanan DG, Do DV, et al. 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;48(4):291–301. doi:10.3928/23258160-20170329-03
   PubMed Web of Science ®Google Scholar
• 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. doi:10.1016/j.ophtha.2011.12.039
   PubMed Web of Science ®Google Scholar
• Bressler SB, Qin H, Beck RW, et al. Factors associated with changes in visual acuity and central subfield thickness at 1 year after treatment for diabetic macular edema with ranibizumab. Arch Ophthalmol. 2012;130(9):1153–1161. doi:10.1001/archophthalmol.2012.1107
   PubMedGoogle Scholar
• Sivaprasad S, Oyetunde S. Impact of injection therapy on retinal patients with diabetic macular edema or retinal vein occlusion. Clin Ophthalmol. 2016;10:939–946. doi:10.2147/OPTH.S100168
   PubMed Web of Science ®Google Scholar
• Weiss M, Sim DA, Herold T, et al. Compliance and adherence of patients with diabetic macular edema to intravitreal anti–vascular endothelial growth factor therapy in daily practice. Retina. 2018;38(12):2293–2300. doi:10.1097/IAE.0000000000001892
   PubMed Web of Science ®Google Scholar
• Ross EL, Hutton DW, Stein JD, Bressler NM, Jampol LM, Glassman AR. Cost-effectiveness of aflibercept, bevacizumab, and ranibizumab for diabetic macular edema treatment: analysis from the Diabetic Retinopathy Clinical Research Network Comparative Effectiveness Trial. JAMA Ophthalmol. 2016;134(8):888–896. doi:10.1001/jamaophthalmol.2016.1669
   PubMed Web of Science ®Google Scholar
• Holekamp NM, Campbell J, Almony A, et al. Vision outcomes following anti-vascular endothelial growth factor treatment of diabetic macular edema in clinical practice. Am J Ophthalmol. 2018;191:83–91. doi:10.1016/j.ajo.2018.04.010
   PubMed Web of Science ®Google Scholar
• Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985;103(12):1796–1806. doi:10.1001/archopht.1985.01050120030015
   PubMedGoogle Scholar
• Early Treatment Diabetic Retinopathy Study Research Group. Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Ophthalmology. 1991;98(5 Suppl):766–785. doi:10.1016/S0161-6420(13)38011-7
   Web of Science ®Google Scholar
• Zhang W, Liu H, Rojas M, Caldwell RW, Caldwell RB. Anti-inflammatory therapy for diabetic retinopathy. Immunotherapy. 2011;3(5):609–628. doi:10.2217/imt.11.24
   PubMed Web of Science ®Google Scholar
• Tang J, Kern TS. Inflammation in diabetic retinopathy. Prog Retin Eye Res. 2011;30(5):343–358. doi:10.1016/j.preteyeres.2011.05.002
   PubMed Web of Science ®Google Scholar
• Ciulla TA, Harris A, McIntyre N, Jonescu-Cuypers C. Treatment of diabetic macular edema with sustained-release glucocorticoids: intravitreal triamcinolone acetonide, dexamethasone implant, and fluocinolone acetonide implant. Expert Opin Pharmacother. 2014;15(7):953–959. doi:10.1517/14656566.2014.896899
   PubMed Web of Science ®Google Scholar
• Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2008;115(9):1447–1459. doi:10.1016/j.ophtha.2008.06.015
   Web of Science ®Google Scholar
• Whitcup SM, Cidlowski JA, Csaky KG, Ambati J. Pharmacology of corticosteroids for diabetic macular edema. Invest Ophthalmol Vis Sci. 2018;59(1):1–12. doi:10.1167/iovs.17-22259
   PubMed Web of Science ®Google Scholar
• 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.2014.04.024
   PubMed Web of Science ®Google Scholar
• 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. doi:10.1016/j.ophtha.2014.07.002
   PubMed Web of Science ®Google Scholar
• Callanan DG, Loewenstein A, Patel SS, et al. A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2017;255(3):463–473. doi:10.1007/s00417-016-3472-1
   PubMed Web of Science ®Google Scholar
• Maturi RK, Glassman AR, Liu D, 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;136(1):29–38. doi:10.1001/jamaophthalmol.2017.4914
   PubMed Web of Science ®Google Scholar
• Kaya M, Kocak N, Ozturk T, Bolluk V, Ayhan Z, Kaynak S. Intravitreal ranibizumab and dexamethasone implant injections as primary treatment of diabetic macular edema: simultaneously double protocol. Eye (Lond). 2021;35(3):777–785. doi:10.1038/s41433-020-0949-2
   Google Scholar
• Rosenblatt A, Udaondo P, Cunha-Vaz J, et al. A collaborative retrospective study on the efficacy and safety of intravitreal dexamethasone implant (Ozurdex) in patients with diabetic macular edema: the European DME Registry Study. Ophthalmology. 2020;127(3):377–393. doi:10.1016/j.ophtha.2019.10.005
   PubMed Web of Science ®Google Scholar
• He Y, Ren XJ, Hu BJ, Lam WC, Li XR. A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema. BMC Ophthalmol. 2018;18(1):121. doi:10.1186/s12886-018-0779-1
   PubMed Web of Science ®Google Scholar
• Urbančič M, Gardašević Topčić I. Dexamethasone implant in the management of diabetic macular edema from clinician’s perspective. Clin Ophthalmol. 2019;13:829–840. doi:10.2147/OPTH.S206769
   PubMed Web of Science ®Google Scholar
• Grover S, Murthy RK, Brar VS, Chalam KV. Comparison of retinal thickness in normal eyes using Stratus and Spectralis optical coherence tomography. Invest Ophthalmol Vis Sci. 2010;51(5):2644–2647. doi:10.1167/iovs.09-4774
   Web of Science ®Google Scholar
• Sabouri MR, Kazemnezhad E, Hafezi V. Assessment of macular thickness in healthy eyes using cirrus HD-OCT: a cross-sectional study. Med Hypothesis Discov Innov Ophthalmol. 2016;5(3):104–111.
   Google Scholar
• Romero-Aroca P, Reyes-Torres J, Baget-Bernaldiz M, Blasco-Suñe C. Laser treatment for diabetic macular edema in the 21st century. Curr Diabetes Rev. 2014;10(2):100–112. doi:10.2174/1573399810666140402123026
   PubMedGoogle Scholar
• Haller JA, Bandello F, Belfort R Jr, et al. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010;117(6):1134–1146.e1133. doi:10.1016/j.ophtha.2010.03.032
   PubMed Web of Science ®Google Scholar
• Callanan DG, Gupta S, Boyer DS, et al. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013;120(9):1843–1851. doi:10.1016/j.ophtha.2013.02.018
   PubMed Web of Science ®Google Scholar
• 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(4):615–625. doi:10.1016/j.ophtha.2011.01.031
   PubMed Web of Science ®Google Scholar
• Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247–2254. doi:10.1016/j.ophtha.2014.05.006
   PubMed Web of Science ®Google Scholar
• Singer MA, Dugel PU, Fine HF, Capone A Jr., Maltman J. Real-world assessment of dexamethasone intravitreal implant in DME: findings of the prospective, multicenter REINFORCE study. Ophthalmic Surg Lasers Imaging Retina. 2018;49(6):425–435. doi:10.3928/23258160-20180601-07
   Web of Science ®Google Scholar
• Li X, Wang N, Liang X, et al. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018;256(1):59–69. doi:10.1007/s00417-017-3831-6
   PubMed Web of Science ®Google Scholar
• Tufail A, Lightman S, Kamal A, et al. Post-marketing surveillance study of the safety of dexamethasone intravitreal implant in patients with retinal vein occlusion or noninfectious posterior segment uveitis. Clin Ophthalmol. 2018;12:2519–2534. doi:10.2147/OPTH.S181256
   PubMed Web of Science ®Google Scholar
• Busch C, Fraser-Bell S, Iglicki M, et al. Real-world outcomes of non-responding diabetic macular edema treated with continued anti-VEGF therapy versus early switch to dexamethasone implant: 2-year results. Acta Diabetol. 2019;56(12):1341–1350.
   Web of Science ®Google Scholar
• Ruiz-Medrano J, Rodríguez-Leor R, Almazán E, et al. Results of dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema patients: early versus late switch. Eur J Ophthalmol. 2021;31(3):1135–1145. doi:10.1177/1120672120929960
   Web of Science ®Google Scholar