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

Volumn 10, Issue , 2016, Pages 1257-1264

  Massin, Pascale ^a   Erginay, Ali ^a   Dupas, Bénédicte ^a   Couturier, Aude ^a   Tadayoni, Ramin ^a  

^a HÔPITAL LARIBOISIÈRE   (France)

Author keywords

Corticosteroid intravitreal implant; Diabetic macular edema; Fluocinolone acetonide; Intravitreal corticosteroid

Indexed keywords

FLUOCINOLONE ACETONIDE; VASCULOTROPIN INHIBITOR;

ADULT; AGED; ARTICLE; CENTRAL SUBFIELD THICKNESS; CLINICAL ARTICLE; CONTROLLED STUDY; DIABETIC MACULAR EDEMA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; INTRAOCULAR PRESSURE; INTRAVITREAL IMPLANT; LASER COAGULATION; MALE; OPEN STUDY; PATIENT SELECTION; PHASE 4 CLINICAL TRIAL; PROSPECTIVE STUDY; PSEUDOPHAKIA; SIDE EFFECT; SUSTAINED DRUG RELEASE; VISUAL ACUITY; VISUAL SYSTEM PARAMETERS;

EID: 84982703166     PISSN: 11775467     EISSN: 11775483     Source Type: Journal    
DOI: 10.2147/OPTH.S105385     Document Type: Article

References (34)

1. Klein R, Lee KE, Gangnon RE, Klein BE. The 25-year incidence of visual impairment in type 1 diabetes mellitus the wisconsin epidemiologic study of diabetic retinopathy. Ophthalmology. 2010;117(1):63-70
2. Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998;105(6):998-1003
3. Yau JW, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35(3):556-564
4. Minassian DC, Owens DR, Reidy A. Prevalence of diabetic macular oedema and related health and social care resource use in England. Br J Ophthalmol. 2012;96(3):345-349
5. Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XV. The long-term incidence of macular edema. Ophthalmology. 1995;102(1):7-16
6. Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009;54(1):1-32
7. Antonetti DA, Lieth E, Barber AJ, Gardner TW. Molecular mechanisms of vascular permeability in diabetic retinopathy. Semin Ophthalmol. 1999; 14(4):240-248
8. Ehrlich R, Harris A, Ciulla TA, Kheradiya N, Winston DM, Wirostko B. Diabetic macular oedema: physical, physiological and molecular factors contribute to this pathological process. Acta Ophthalmol. 2010;88(3): 279-291
9. 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
10. Joussen AM, Poulaki V, Le ML, et al. A central role for inflammation in the pathogenesis of diabetic retinopathy. FASEB J. 2004;18(12): 1450-1452
11. Klaassen I, Van Noorden CJ, Schlingemann RO. Molecular basis of the inner blood-retinal barrier and its breakdown in diabetic macular edema and other pathological conditions. Prog Retin Eye Res. 2013;34: 19-48
12. Tang J, Kern TS. Inflammation in diabetic retinopathy. Prog Retin Eye Res. 2011;30(5):343-358
13. Funatsu H, Yamashita H, Noma H, et al. Aqueous humor levels of cytokines are related to vitreous levels and progression of diabetic retinopathy in diabetic patients. Graefes Arch Clin Exp Ophthalmol. 2005; 243(1):3-8
14. Dong N, Xu B, Wang B, Chu L. Study of 27 aqueous humor cytokines in patients with type 2 diabetes with or without retinopathy. Mol Vis. 2013; 19:1734-1746
15. Das A, McGuire PG, Rangasamy S. Diabetic macular edema: pathophysiology and novel therapeutic targets. Ophthalmology. 2015;122(7): 1375-1394
16. Wells JA, Glassman AR, Ayala AR, et al; Diabetic Retinopathy Clinical Research Network. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372(13):1193-1203
17. Avery RL, Gordon GM. Systemic safety of prolonged monthly anti-vascular endothelial growth factor therapy for diabetic macular edema: a systematic review and meta-analysis. JAMA Ophthalmology. 2015:21-29
18. Callanan DG, Gupta S, Boyer DS, et al; Ozurdex PLACID Study Group. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013;120(9):1843-1851
19. Kane FE, Burdan J, Cutino A, Green KE. Iluvien: a new sustained delivery technology for posterior eye disease. Expert Opin Drug Deliv. 2008;5(9):1039-1046
20. Campochiaro PA, Nguyen QD, Hafiz G, et al; FAMOUS Study Group. Aqueous levels of fluocinolone acetonide after administration of fluocinolone acetonide inserts or fluocinolone acetonide implants. Ophthalmology. 2013;120(3):583-587
21. Campochiaro PA, Brown DM, Pearson A, et al; FAME Study Group. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119(10):2125-2132
22. Campochiaro PA, Brown DM, Pearson A, et al; FAME Study Group. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118(4): 626-635
23. ILUVIEN®. Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/medicine/27636. Accessed May 30, 2016
24. Bressler SB, Qin H, Beck RW, et al; Diabetic Retinopathy Clinical Research Network. 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
25. Browning DJ, Glassman AR, Aiello LP, et al; Diabetic Retinopathy Clinical Research Network. Relationship between optical coherence tomography-measured central retinal thickness and visual acuity in diabetic macular edema. Ophthalmology. 2007;114(3):525-536
26. Alasil T, Keane PA, Updike JF, et al. Relationship between optical coherence tomography retinal parameters and visual acuity in diabetic macular edema. Ophthalmology. 2010;117(12):2379-2386
27. Uji A, Murakami T, Nishijima K, et al. Association between hyperreflective foci in the outer retina, status of photoreceptor layer, and visual acuity in diabetic macular edema. Am J Ophthalmol. 2012;153(4): 710-717
28. Sakamoto A, Nishijima K, Kita M, Oh H, Tsujikawa A, Yoshimura N. Association between foveal photoreceptor status and visual acuity after resolution of diabetic macular edema by pars plana vitrectomy. Graefes Arch Clin Exp Ophthalmol. 2009;247(10):1325-1330
29. Bonnin S, Tadayoni R, Erginay A, Massin P, Dupas B. Correlation between ganglion cell layer thinning and poor visual function after resolution of diabetic macular edema. Invest Ophthalmol Vis Sci. 2015; 56(2):978-982
30. Carpineto P, Ciancaglini M, Di Antonio L, Gavalas C, Mastropasqua L. Fundus microperimetry patterns of fixation in type 2 diabetic patients with diffuse macular edema. Retina. 2007;27(1):21-29
31. Vujosevic S, Pilotto E, Bottega E, Benetti E, Cavarzeran F, Midena E. Retinal fixation impairment in diabetic macular edema. Retina. 2008; 28(10):1443-1450
32. Dubois-Roussel C, Dupas B, Erginay A, Massin P, Tadayoni R. Increased fixation stability after intravitreal treatment for chronic diabetic macular edema: a marker of favorable visual outcome. Poster 1777 - A0210 presented at: 2015 Annual meeting of the Association for Research in Vision and Ophtalmology (ARVO); May 3-7, 2015; Denver, Colorado.
33. Schmit-Eilenberger VK. A novel intravitreal fluocinolone acetonide implant (Iluvien®) in the treatment of patients with chronic diabetic macular edema that is insufficiently responsive to other medical treatment options: a case series. Clin Ophthalmol. 2015;9:801-811
34. Downey L, Chakravarthy U. Exploratory analyses of long-term visual outcomes based on baseline vision in patients with chronic and nonchronic diabetic macular oedema (DMO) treated with fluocinolone acetonide (FAc). Poster 221 presented at: Annual Congress 2015 of the The Royal College of Ophthalmologists; May 19-21, 2015, Liverpool, UK.