<p>Clinical-Decision Criteria to Identify Recurrent Diabetic Macular Edema Patients Suitable for Fluocinolone Acetonide Implant Therapy (ILUVIEN^®) and Follow-Up Considerations/Recommendations</p>

Abstract

Current management of diabetic macular edema (DME) predominantly involves treatment with short-acting intravitreal injections of anti-vascular endothelial growth factors (anti-VEGFs) and/or corticosteroids; however, short-acting therapies (lasting between 1 and 6 months) require frequent injections to maintain efficacy, meaning a considerable treatment burden for diabetic patients with multiple comorbidities. Continuous injections needed in some cases are an economic burden for patients/healthcare system, so real-life clinical practice tends to adopt a reactive approach, ie, watch and wait for worsening symptoms, which consequently increases the risk of undertreatment and edema recurrence. On March 7th 2019, a group of experts in retinal medicine and surgery held a roundtable meeting in Madrid, Spain to discuss how to (1) optimize clinical outcomes through earlier use of fluocinolone acetonide (FAc) implant (ILUVIEN ®) in patients with persistent or recurrent DME despite therapy; and, (2) to provide guidance to assist physicians in deciding which patients should be treated with ILUVIEN. In this regard, a 36-month follow-up consensus protocol is presented. In conclusion, patients that achieve a complete or partial anatomical, and preferably functional, response following one or two intravitreal dexamethasone implants, but with recurrence of edema after 3-4 months, are deemed by the authors most likely to benefit from ILUVIEN, and the switch to FAc implant should not be delayed more than 12 months after the initiation of at least the first dexamethasone implant.

Extended real-world experience with the ILUVIEN® (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft® audit study

“…In these cases, the mean time to the second implant was around 3.2 years and shows that the FAc implant can provide 3 years (or more) of therapy and reinforces its low clinical and treatment burden in real-world UK practice. The number of second injections is lower than that reported in the FAME study (1.3 injections over 3 years) [ 22 ]. This may be particularly relevant in the current pandemic, in which it is beneficial to have treatments available that may facilitate less frequent clinic visits and fewer injection visits.…”

Optical Coherence Tomography Features Predicting the Response of Diabetic Macular Oedema to Treatment with Fluocinolne Acetonide Intravitreal Implant, a Cohort Study.

“…A good response to treatment with fluocinolone acetonide is reported to be achieved in patients with a complete anatomical response after one injection of dexamethasone implant for those patients in whom the retina layers are preserved 8,9 .…”

Intraocular Pressure Changes After Intravitreal Fluocinolone Acetonide Implant: Results from Four European Countries

“…To our knowledge, very few studies have investigated optic nerve damage in steroid-induced IOP elevation after an FAc intravitreal implant [ 22 , 45 ]. In future studies, we should monitor the optic nerve head structure and function to follow the recommendations for the management of elevated IOP after an FAc intravitreal implant [ 39 , 46 ]. Second, our follow-up period was short compared to the duration of the FAc effectiveness, which lasts up to 36 months.…”