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

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.

Keywords: DME; ILUVIEN; diabetic macular edema; fluocinolone acetonide implant therapy.

Figure 1

FA levels in human aqueous humor in subjects receiving one ILUVIEN^® implant (FAMOUS Study). Notes: Data from Campochiaro et al. FAc, 0.2 μg/day fluocinolone acetonide (ILUVIEN).

Figure 2

Percentage of subjects with ≥15 letter improvement from baseline in best corrected visual acuity (BCVA) at 24 and 36 months in patients with DME treated with 0.2 μg/day FAc implant versus sham injection. Notes: Data from Campochiaro et al. , and ILUVIEN^® Spanish Summary of Product Characteristics. *P = 0.002 FAc vs sham at Month 24; **P < 0.018 FAc vs sham at Month 36; ***P < 0.001 FAc vs sham for both at Month 24 and 36. Full study population, N= 376 (FAc), N = 185 (sham); Chronic DME subgroup, N = 207 (FAc), N = 111 (sham). Abbreviation: DME, diabetic macular edema; FAc, 0.2 μg fluocinolone acetonide (ILUVIEN).

Figure 3

Mean gains in best corrected visual acuity (BVCA) from baseline at 24 and 36 months in patients with chronic DME treated with 0.2 μg/day FAc implant. Notes: *P = 0.35 vs sham at Month 24; **P = 0.04 vs sham at Month 36.; FAc, 0.2 μg fluocinolone acetonide. Abbreviations: DME, diabetic macular edema; FAc, 0.2 μg fluocinolone acetonide (ILUVIEN^®).

Figure 4

Mean central foveal thickness (CFT) change in patients with chronic DME treated with 0.2 μg/day FAc implant. Notes: Data from Campochiaro et al., and ILUVIEN^® Spanish Summary of Product Characteristics. *P = 0.005 vs sham at Month 24. Abbreviation: DME, diabetic macular edema; FAc, 0.2 μg fluocinolone acetonide (ILUVIEN).

Figure 5

ILUVIEN^® indication and follow-up pathway.

Figure 6

Algorithm for the management of IOP elevation by retinal specialists: pre- (top panels) and post-corticosteroid injection (bottom panels). Note: Adapted from Goni et al.