Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials

Current Medical Research and Opinion

Volumn 35, Issue 7, 2019, Pages 1165-1176

  Holden, Sarah E ^a   Kapik, Barry ^b   Beiderbeck, Annette B ^b   Currie, Craig J ^a,c  

^a Pharmatelligence   (United Kingdom)

^b Alimera Sciences Limited   (United States)

^c CARDIFF UNIVERSITY   (United Kingdom)

Author keywords

Comparison; Diabetic macular edema; FAME; Fluocinolone; ICE UK

Indexed keywords

FLUOCINOLONE ACETONIDE; PRESCRIPTION DRUG; STEROID; VASCULOTROPIN INHIBITOR; GLUCOCORTICOID;

ADULT; ARTICLE; CATARACT EXTRACTION; CENTRAL FOVEAL THICKNESS; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; COMPARATIVE STUDY; CONTROLLED STUDY; DESCRIPTIVE RESEARCH; DEVICE SAFETY; DIABETIC MACULAR EDEMA; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; INTERVENTION STUDY; INTRAOCULAR PRESSURE; LASER COAGULATION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; OBSERVATIONAL STUDY; OPTICAL COHERENCE TOMOGRAPHY; OUTCOME ASSESSMENT; PRESCRIPTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SHAM PROCEDURE; STEROID THERAPY; TREND STUDY; VISUAL ACUITY; VISUAL SYSTEM PARAMETERS; AGED; DIABETIC RETINOPATHY; DRUG EFFECT; DRUG IMPLANT; INTRAVITREAL DRUG ADMINISTRATION; MACULAR EDEMA; TREATMENT OUTCOME; UNITED KINGDOM;

AGED; DIABETIC RETINOPATHY; DRUG IMPLANTS; FEMALE; FLUOCINOLONE ACETONIDE; GLUCOCORTICOIDS; HUMANS; INTRAOCULAR PRESSURE; INTRAVITREAL INJECTIONS; MACULAR EDEMA; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; UNITED KINGDOM; VISUAL ACUITY;

EID: 85060244421     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1080/03007995.2018.1560779     Document Type: Article

References (21)

1. National Institute for Health and Care Excellence. Fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema after an inadequate response to prior therapy. London; 2013 [cited 2014 Oct 24]. Available from: www.nice.org.uk/guidance/ta301.
2. 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;119:2125–2132.
3. electronic medicines compendium. SPC ILUVIEN 190 micrograms intravitreal implant in applicator. EMC; 2015 [cited 2016 Oct 20]. Available from: https://www.medicines.org.uk/emc/medicine/27636.
4. Medicines and Healthcare products Regulatory Agency. Public assessment report. Mutual recognition procedure. ILUVIEN ® 190 micrograms intravitreal implant in applicator (fluocinolone acetonide). London; 2015 [cited 2016 Oct 20]. Available from: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con171936.pdf.
5. Campochiaro PA, Brown DM, Pearson A, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118:626–635.
6. Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. Two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology. 2016;123:1351–1359.
7. Brown DM, Nguyen QD, Marcus DM, et al. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology. 2013;120:2013–2022.
8. Elman MJ, Ayala A, Bressler NM, et al. Intravitreal ranibizumab for diabetic macular edema with prompt vs. deferred laser treatment: 5-year randomized trial results. Ophthalmology. 2015;122:375–381.
9. The Diabetic Retinopathy Clinical Research Network. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372:1193–1203.
10. National Institute for Health and Care Excellence. Ranibizumab for treating diabetic macular oedema. Technology appraisal guidance [TA274]. London; 2013 [cited 2013 Feb 27]. Available from: https://www.nice.org.uk/guidance/ta274.
11. National Institute for Health and Care Excellence. Aflibercept for treating diabetic macular oedema. Technology appraisal guidance [TA346]. London; 2015 [cited 2016 May 8]. Available from: https://www.nice.org.uk/guidance/ta346.
12. Gonzalez VH, Campbell J, Holekamp NM, et al. Early and long-term responses to anti-vascular endothelial growth factor therapy in diabetic macular edema: analysis of protocol I data. Am J Ophthalmol. 2016;172:72–79.
13. Holden SE, Currie CJ, Owens DR. Evaluation of the clinical effectiveness in routine practice of fluocinolone acetonide 190 µg intravitreal implant in people with diabetic macular edema. Curr Med Res Opin. 2017;33(supp 2):5–17.
14. Currie CJ, Holden SE, Berni E, et al. Evaluation of the clinical effectiveness of fluocinolone acetonide 190 µg intravitreal implant in diabetic macular edema: a comparison between study and fellow eyes. Curr Med Res Opin. 2017;33(supp 2):19–31.
15. European Medicines Agency. Questions and answers following the initial experience of the Adaptive Licensing Pilot project. London; 2014 [cited 2017 Feb 21]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/09/WC500172810.pdf.
16. 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.
17. Currie CJ, Holden SE, Owens DR. Patterns of retinal thickness prior to and following treatment with fluocinolone acetonide 190 µg intravitreal implant for diabetic macular edema. Curr Med Res Opin. 2017;33(supp 2):33–43.
18. Gregori NZ, Feuer W, Rosenfeld PJ. Novel method for analyzing snellen visual acuity measurements. Retina. 2010;30:1046–1050.
19. Yang Y, Bailey C, Holz FG, et al. Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants. Eye. 2015;29:1173–1180.
20. Wolf-Schnurrbusch UEK, Ceklic L, Brinkmann CK, et al. Macular thickness measurements in healthy eyes using six different optical coherence tomography instruments. Invest Ophthalmol Vis Sci. 2009;50:3432–3437.
21. The Diabetic Retinopathy Clinical Research Network/Writing Committee, Bressler SB, Edwards AR, et al. Reproducibility of spectral domain optical coherence tomography retinal thickness measurements and conversion to equivalent time domain metrics in diabetic macular edema. JAMA Ophthalmol. 2014;132:1113–1122.