This article reports 12-month outcomes of patients with diabetic macular edema previously treated with other antivascular endothelial growth factor agents and transitioned to fixed dosing of intravitreal aflibercept (IAI).
Methods:
This prospective, single-arm study enrolled patients to receive IAI 2 mg (0.05 mL) every 4 weeks until optical coherence tomography demonstrated no fluid. Patients then received fixed dosing of IAI 2 mg once every 8 weeks through 12 months. Primary outcome was mean absolute change from baseline central subfield thickness (CST) at 12 months measured by optical coherence tomography.
Results:
Twenty eyes were enrolled. At baseline, best-corrected visual acuity was 70.0 letters, mean CST was 419.7 µm ± 92.0, superficial capillary perfusion density (CPD) was 46.0 ± 4.2%, and deep CPD was 50.8 ± 4.3%. At 12 months, the mean CST improved to 287.2 µm ± 80.2 (P < .001), superficial CPD decreased to 43.6 ± 4.8% (P = .04), and deep CPD decreased to 47.6 ± 4.8% (P = .05).
Conclusions:
Patients who switched to fixed dosing of IAI demonstrated significant anatomic improvements in CST at 12 months. CPD values decreased significantly both in superficial and deep layers without significant changes in vision.
SabanayagamCYipWTingDSTanGWongTY. Ten emerging trends in the epidemiology of diabetic retinopathy. Ophthalmic Epidemiol. 2016;23(4):209–222. doi:10.1080/09286586.2016.1193618
2.
NguyenQDTatlipinarSShahSM, et al.Vascular endothelial growth factor is a critical stimulus for diabetic macular edema. Am J Ophthalmol. 2006;142(6):961–969. doi:10.1016/j.ajo.2006.06.068
3.
FunatsuHYamashitaHNomaHMimuraTYamashitaTHoriS. Increased levels of vascular endothelial growth factor and interleukin-6 in aqueous humor of diabetics with macular edema. Am J Ophthalmol. 2002;133(1):70–77. doi:10.1016/s0002-9394(01)01269-7
4.
SolomonSDChewEDuhEJ, et al.Diabetic retinopathy: a position statement by the American Diabetic Association. Diabetes Care. 2017;30(3):412–418. doi:10.2337/dc16-2641
5.
MitchellPBandelloFSchmidtErfurth, 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
6.
NguyenQDShahSMKhwajaAA, et al.Two-year outcomes of ranibizumab for edema of the macula in diabetes (READ-2) study. Ophthalmology. 2010;117(11):2146–2151. doi:10.1016/j.ophtha.2010.08.016
7.
NguyenQDBrownDMMarcusDM. 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
8.
MichaelidesMKainesAHamiltonRD, et al.A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2. Ophthalmology. 2010;117(6):1078–1086. doi:10.1016/j.ophtha.2010.03.045
9.
KorobelnikJFDoDVSchmidt-ErfurthU, et al.Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247–2254. doi:10.1016/j.ophtha.2014.05.006
10.
WellsJAGlassmanARAyalaAR, et al.Diabetic Retinopathy Clinical Research Network. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372(13):1193–1203. doi:10.1056/NEJMoa1414264
11.
Schmidt-ErfurthULangGEHolzFG, et al.Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study. Ophthalmology. 2014;121(5):1045–1053. doi:10.1016/j.ophtha.2013.11.041
12.
ElmanMJBresslerNMQinH, et al.Diabetic Retinopathy Clinical Research Network. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011;118(4):609–614. doi:10.1016/j.ophtha.2010.12.033
13.
BresslerNMBeaulieuWTGlassmanAR, et al.Persistent macular thickening following intravitreous aflibercept, bevacizumab, or ranibizumab for central-involved diabetic macular edema with vision impairment: a secondary analysis of a randomized clinical trial. JAMA Ophthalmol. 2018;126(3):257–269. doi:10.1001/jamaophthalmol.2017.6565
14.
BabiuchAContiTContiF, et al.Diabetic macular edema treated with intravitreal aflibercept injection after treatment with other anti-VEGF agents (SWAP-TWO Study): 6-month interim analysis. Int J Retina Vitreous. 2019;5:17. doi:10.1186/s40942-019-0167-x
15.
BeckRWMokePSTurpinAH, et al.A computerized method of visual acuity testing: adaptation of the Early Treatment of Diabetic Retinopathy Study testing protocol. Am J Ophthalmol. 2003;135(2):194–205. doi:10.1016/s0002-9394(02)01825-1
LaiginhasRSilvaMIRosasV, et al.Aflibercept in diabetic macular edema refractory to previous bevacizumab: outcomes and predictors of success. Graefes Arch Clin Exp Ophthalmol. 2018;256(1):83–89. doi:10.1007/s00417-017-3836-1
18.
BanaeeTAshrafMContiFFSinghRP. Switching anti-VEGF drugs in the treatment of diabetic macular edema. Ophthalmic Surg Lasers Imaging Retina. 2017;48(9):748–754. doi:10.3928/23258160-20170829-10
19.
AshrafMSoukaAAElKayalH. Short-term effects of early switching to ranibizumab or aflibercept in diabetic macular edema cases with non-response to bevacizumab. Ophthalmic Surg Lasers Imaging Retina. 2017;48(3):230–236. doi:10.3928/23258160-20170301-06
20.
ShahCPHeierJS. Aflibercept for diabetic macular edema in eyes previously treated with ranibizumab and/or bevacizumab may further improve macular thickness. Ophthalmic Surg Lasers Imaging Retina. 2016;47(9):836–839. doi:10.3928/23258160-20160901-06
21.
LimLSNgWYMathurR, et al.Conversion to aflibercept for diabetic macular edema unresponsive to ranibizumab or bevacizumab. Clin Ophthalmol. 2015;9:1715–1718. doi:10.2147/OPTH.S81523
22.
LeeJHLeeWKKimSE. Short-term outcomes of switching to ranibizumab therapy for diabetic macular edema in patients with persistent fluid after bevacizumab therapy. J Ocul Pharmacol Ther. 2016;32(10):659–664. doi:10.1089/jop.2016.0074
23.
SamaraWAShahlaeeAAdamMK, et al.Quantification of diabetic macular ischemia using optical coherence tomography angiography and its relationship with visual acuity. Ophthalmology. 2017;124(2):235–244. doi:10.1016/j.ophtha.2016.10.008
24.
AgemySAScripsemaNKShahCM, et al.Retinal vascular perfusion density mapping using optical coherence tomography angiography in normal and diabetic retinopathy patients. Retina. 2015;35(11):2353–2363. doi:10.1097/IAE.0000000000000862
25.
MastropasquaRTotoLMastropasquaA, et al.Foveal avascular zone area and parafoveal vessel density measurements in different stages of diabetic retinopathy by optical coherence tomography angiography. Int J Ophthalmol. 2017;10(10):1545–1551. doi:10.18240/ijo.2017.10.11
26.
AttaAllahHRMohamedAAMAliMA. Macular vessel density in diabetic retinopathy: quantitative assessment using optical coherence tomography angiography. Int Ophthalmol. 2019;39(8):1845–1859. doi:10.1007/s10792-018-1013-0
27.
WilkinsonCPFerrisFL IIIKleinRE, et al.Global Diabetic Retinopathy Project Group. Proposed international clinical diabetic retinopathy and diabetic retinopathy macular edema disease severity scales. Ophthalmology. 2003;110(9):1677–1682. doi:10.1016/S0161-6420(03)00475-5
