Diabetic macular oedema: good news from the first 3-year real-life data of patients treated with fluocinolone acetonide

Pubblicato il

Tuesday, 9 April 2019

Argomento

Retina

Patients with diabetic macular oedema (EMD) that do not respond sufficiently to first-line treatments (laser and anti-VEGF therapy), can be treated with a fluocinolone acetonide (FAc) implant, which is injected into the vitreous where it releases a microdose of FAc (0.2 μg per day), continuously, for up to 3 years with the aim of reducing macular oedema and improving vision.

The effectiveness of AFc implantation in patients with diabetic macular oedema

A retrospective study was recently published, called retro-IDEAL, which evaluates for the first time, safety and efficacy, on patients with chronic diabetic macular oedema, of the FAc implant in real lifeor in everyday clinical practice, for the entire 3-year life of the plant from the start of treatment.

The analysis was carried out on a total of 94 eyes belonging to 76 patients, extracts from the records of German clinics. It is important to emphasise that These patients were among the first treated in Germany after the approval of the use of FAc and presented with an acute state of inflammatory disease, determined by long-term diabetic macular oedema and the heavy course of first-line treatments (laser or anti-VEGF) administered prior to receiving AFc implantation as second-line treatment.

The study shows that patients, followed for 30.8 (± 11.3) months, had an improved visual acuity (AV) of +5.5 letters in the ninth month e maintained until month 30. The study also showed, in the first year, a reduction in the thickness of the central macula (from 502 μm at baseline to 338 μm), started at month 3 and maintained until year 3. The mean intraocular pressure (IOP, intraocular pression) remained constant between baseline and year 3with a maximum change of 1.9 mmHg occurring at year 1. These data confirm those of another large study, published on FAc implantation, which included 305 patients with a 2-year follow-up. The authors (Bailey et al.) again reported improvements in both mean AV (from 51.9 to 57.2 letters) and central foveal thickness (reduction from 451.2 to 355.5 μm).

Retro-IDEAL represents, therefore, the first analysis covering a follow-up period of 3 years (an average of 30.8 months), which confirms that treatment with an FAc, in patients who had not previously achieved optimal results with anti-VEGF therapies, offers clinically significant improvements in AV and macular thickness over the life of the implant.

The continuous dosing, ensured by the FAc implant, allows not only the constant maintenance of the treatment, even in the case of delays at follow-up appointments, but it also represents an important benefit since many factors - including suboptimal patient compliance - can interrupt the repeated dosing schedule that is often necessary to achieve optimal results in the case of anti-VEGF therapy.