Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries

Usha Chakravarthy, Simon R Taylor, Frank H Johannes Koch, João Paulo Castro de Sousa, Clare Bailey, ILUVIEN Registry Safety Study (IRISS) Investigators Group, Usha Chakravarthy, Simon R Taylor, Frank H Johannes Koch, João Paulo Castro de Sousa, Clare Bailey, ILUVIEN Registry Safety Study (IRISS) Investigators Group

Abstract

Aims: The ILUVIEN Registry Safety Study is an ongoing, multicentre, open-label, observational study collecting real-world data on the safety and effectiveness of the 0.2 µg/day fluocinolone acetonide (FAc) implant in patients treated according to the European label requirements.

Methods: Patients included in this analysis were treated for the licensed indication of chronic diabetic macular oedema (cDMO; that is, DMO that persists or recurs despite treatment). Data presented in the current analysis were collected from patient records up to 6 March 2017. Visual acuity (VA) data, including mean change in VA over time and at last observation, intraocular pressure (IOP) over the course of the study, IOP events, use of IOP-lowering therapy and cup:disc ratio were analysed. Information on additional DMO treatments post-FAc implant was also captured.

Results: Five hundred and sixty-three patients (593 eyes) were enrolled on the study. Mean IOP for the overall population remained within the normal range throughout follow-up and 76.7% of patients did not require IOP-lowering therapy following treatment with the FAc implant. Sixty-nine per cent of eyes did not require additional DMO treatments. Mean VA in the overall population increased from 51.9 letters at baseline to 55.6 letters at month 12, with a significant increase of 2.9 letters at last observation. Patients with short-term cDMO experienced greater VA gains than those with long-term cDMO.

Conclusions: The results of this analysis are comparable with those of other studies, including the Fluocinolone Acetate for Macular Edema study. The study reinforces the good safety and effectiveness profile of FAc, and demonstrates the benefit of early FAc treatment.

Keywords: clinical trial; macula; pharmacology; retina.

Conflict of interest statement

Competing interests: UC is a speaker and advisory board member for Alimera Sciences, an advisory board member for Allergan, Bayer, Novartis and Roche, and has received grants from Bayer, Novartis and Roche. SRT reports financial relationships with GlaxoSmithKline and Novartis, and speaker honoraria, advisory boards and travel grants from Alimera Sciences, Allergan, Bayer, GlaxoSmithKline, Novartis and Santen. FHJK reports a commercial relationship with Alimera Sciences. JPCdS reports no conflicts of interest. CB reports financial support from Alcon, Alimera Sciences, Allergan, Bayer and Novartis.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
VA stability or improvement in IRISS compared with FAME. cDMO, chronic diabetic macular oedema; FAME, Fluocinolone Acetate for Macular Edema; IRISS, ILUVIEN Registry Safety Study; VA, visual acuity.
Figure 2
Figure 2
AUC for phakic and pseudophakic subgroups. AUC, area under the visual acuity-versus-time curve.
Figure 3
Figure 3
Mean change in VA over time by cDMO duration. cDMO, chronic diabetic macular oedema; VA, visual acuity.

References

    1. Klein R, Klein BEK, Moss SE, et al. . The Wisconsin epidemiologic study of diabetic retinopathy XV. Ophthalmology 1995;102:7–16. 10.1016/S0161-6420(95)31052-4
    1. Yau JW, Rogers SL, Kawasaki R, et al. . Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care 2012;35:556–64. 10.2337/dc11-1909
    1. Boyer DS, Hopkins JJ, Sorof J, et al. . Anti-vascular endothelial growth factor therapy for diabetic macular edema. Ther Adv Endocrinol Metab 2013;4:151–69. 10.1177/2042018813512360
    1. Dong N, Xu B, Wang B, et al. . Study of 27 aqueous humor cytokines in patients with type 2 diabetes with or without retinopathy. Mol Vis 2013;19:1734–46.
    1. Dong N, Xu B, Chu L, et al. . Study of 27 aqueous humor cytokines in type 2 diabetic patients with or without macular edema. PLoS One 2015;10:e0125329 10.1371/journal.pone.0125329
    1. Romero-Aroca P, Baget-Bernaldiz M, Pareja-Rios A, et al. . Diabetic macular edema pathophysiology: vasogenic versus inflammatory. J Diabetes Res 2016;2016:1–17. 10.1155/2016/2156273
    1. Boyer DS, Nguyen QD, Brown DM, et al. . Outcomes with as-needed ranibizumab after initial monthly therapy: long-term outcomes of the phase III RIDE and RISE Trials. Ophthalmology 2015;122:2504–13. 10.1016/j.ophtha.2015.08.006
    1. Sohn HJ, Han DH, Kim IT, et al. . Changes in aqueous concentrations of various cytokines after intravitreal triamcinolone versus bevacizumab for diabetic macular edema. Am J Ophthalmol 2011;152:686–94. 10.1016/j.ajo.2011.03.033
    1. Campochiaro PA, Brown DM, Pearson A, et al. . Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology 2012;119:2125–32. 10.1016/j.ophtha.2012.04.030
    1. Campochiaro PA, Brown DM, Pearson A, et al. . Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology 2011;118:626–35. 10.1016/j.ophtha.2010.12.028
    1. Bailey C, Chakravarthy U, Lotery A, et al. . Real-world experience with 0.2 μg/day fluocinolone acetonide intravitreal implant (ILUVIEN) in the United Kingdom. Eye 2017;31:1707–15. 10.1038/eye.2017.125
    1. Medicines and Healthcare Products Regulatory Agency. 2018. Iluvien 190 micrograms intravitreal implant in applicator. Public Assessment Report. PL 41472/0001; UK/H/3011/001/E01. .
    1. Gross JG, Glassman AR, Jampol LM, et al. . Panretinal photocoagulation vs intravitreous ranibizumab for proliferative diabetic retinopathy: a randomized clinical trial. JAMA 2015;314:2137–46. 10.1001/jama.2015.15217
    1. Boyer DS, Yoon YH, Belfort R, et al. . Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology 2014;121:1904–14. 10.1016/j.ophtha.2014.04.024
    1. Daruich A, Matet A, Behar-Cohen F. Sustained-release steroids for the treatment of diabetic macular edema. Curr Diab Rep 2015;15:99 10.1007/s11892-015-0669-3
    1. Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology 2008;115:1447–59. 10.1016/j.ophtha.2008.06.015
    1. Diabetic Retinopathy Clinical Research Network (), Beck RW, Edwards AR, et al. . Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol 2009;127:245–51. 10.1001/archophthalmol.2008.610
    1. Parrish RK, Campochiaro PA, Pearson PA, et al. . Characterization of intraocular pressure increases and management strategies following treatment with fluocinolone acetonide intravitreal implants in the FAME trials. Ophthalmic Surg Lasers Imaging Retina 2016;47:426–35. 10.3928/23258160-20160419-05
    1. Parrish RK, Traverso CE, Green K, et al. . Quantitative assessment of optic nerve changes in patients with diabetic macular edema treated with fluocinolone acetonide vitreous implants. Ophthalmic Surg Lasers Imaging Retina 2016;47:418–25. 10.3928/23258160-20160419-04
    1. Bertelmann T, Schulze S. Long-term follow-up of patient with diabetic macular edema receiving fluocinolone acetonide intravitreal implant. Ophthalmol Ther 2015;4:51–8. 10.1007/s40123-015-0028-0
    1. Elaraoud I, Andreatta W, Kidess A, et al. . Use of fluocinolone acetonide for patients with diabetic macular oedema: patient selection criteria and early outcomes in real world setting. BMC Ophthalmol 2016;16:3 10.1186/s12886-015-0178-9
    1. 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;9:801–11. 10.2147/OPTH.S79785
    1. Cunha-Vaz J, Ashton P, Iezzi R, et al. . Sustained delivery fluocinolone acetonide vitreous implants: long-term benefit in patients with chronic diabetic macular edema. Ophthalmology 2014;121:1892–903. 10.1016/j.ophtha.2014.04.019

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다