Managing Insufficiently Responsive DMO Patients Post-NICE Guidance

Chakravarthy, Usha; Downey, Louise; Kuppermann, Baruch D.; Bourne, Rupert; Hamilton, Robin; Cudrnak, Tomas

doi:10.17925/eor.2014.08.01.61

Cited by 1 publication

(1 citation statement)

References 14 publications

(18 reference statements)

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“…13 Recently, several case reports have been published, detailing early experiences with FAc intravitreal implants in real-world clinical use at ten treatment centres in Germany and the UK (see Tables 1-3). [20][21][22][23][24][25][26] These reports include 28 cases (eyes) with a mean follow-up of 13 weeks (range 1 to 57 weeks).…”

Section: Real-world Datamentioning

confidence: 99%

Real-world Experience of Fluocinolone Acetonide (0.2 μg/day) Intravitreal Implant in the Treatment of Diabetic Macular Oedema

Quhill¹

2015

European Ophthalmic Review

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Fluocinolone acetonide intravitreal implant (ILUVIEN ® , FAc intravitreal implant) is approved for clinical use in Europe and US for the treatment of diabetic macular oedema (DMO). In Europe, the implant is indicated for chronic DMO patients who are insufficiently responsive to available therapies. The use of FAc intravitreal implants has been shown to be effective in pivotal clinical trial studies. Case reports and case series of FAc intravitreal implants in chronic DMO are now emerging and combined analysis of these reveals interesting findings that complement the findings in the clinical studies. Visual improvement and central retinal thickness reductions are similar to those of the clinical trials, which is surprising given that treatments often perform less well in the real-world. In addition, the incidence of intraocular pressure (IOP) elevations is lower than reported in the clinical studies. However, further follow-up is ongoing and this needs to be confirmed in a larger population of subjects. This article reviews some of these important real-world data and their likely impact on future chronic DMO treatment practice as well as the impact in terms of the functional benefit to patients with impaired vision. KeywordsDiabetic macular oedema (DMO), corticosteroids, fluocinolone acetonide intravitreal implant Disclosure: Fahd Quhill has attended advisory boards and speaker engagements and has been remunerated for these by Alimera Sciences.. The FAc intravitreal implant is a non-bioerodible micro-implantable cylindrical tube (3.5 mm × 0.37 mm) made from polyimide and loaded with 190 µg of FAc 17 that is inserted into the vitreous cavity using a 25-gauge injector, which creates a self-sealing wound. The implant releases 0.2 µg/day of FAc for up to 36 months. 17 The pivotal Fluocinolone Acetonide for Macular Edema (FAME) clinical trials were two large prospective, randomised, controlled studies that followed 953 eyes randomised to receive 0.2 μg/day of FAc (low dose; the licensed dose) or 0.5 μg/day of FAc (high dose) implants or sham. After 3 years, substantial improvements were seen in mean visual acuity in 768 patients treated

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Section: Real-world Datamentioning

confidence: 99%

Real-world Experience of Fluocinolone Acetonide (0.2 μg/day) Intravitreal Implant in the Treatment of Diabetic Macular Oedema

Quhill¹

2015

European Ophthalmic Review

View full text Add to dashboard Cite

show abstract

Managing Insufficiently Responsive DMO Patients Post-NICE Guidance

Cited by 1 publication

References 14 publications

Real-world Experience of Fluocinolone Acetonide (0.2 μg/day) Intravitreal Implant in the Treatment of Diabetic Macular Oedema

Real-world Experience of Fluocinolone Acetonide (0.2 μg/day) Intravitreal Implant in the Treatment of Diabetic Macular Oedema

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