Name

162 - APOLLON – Etude prospective, observationnelle, évaluant la prise en charge, dans la pratique courante, des patients atteints d’œdème maculaire diabétique et initiant un traitement par injection intravitréenne d’aflibercept (Eylea®)

To assess visual and anatomic outcomes in patients with diabetic macular edema (DME) treated with intravitreal aflibercept injection (IVT-AFL) in clinical practice in France.

APOLLON (NCT02924311) is an ongoing, prospective, observational, 2-year study to monitor visual (primary), anatomic, and safety outcomes following IVT-AFL in treatment-naïve or previously treated patients with DME. Previous treatment was defined as any other treatment including anti-VEGF (other than IAI), laser, or steroids. Primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to 12 months. Interim results at 12 months are presented here.

A total of 147 patients had both baseline and 12-month data available; of these, 77 were treatment-naïve and 70 were previously treated. Of those previously treated, 44 had prior treatment with ranibizumab and 41 photocoagulation laser. Baseline demographics were largely similar between groups. Patients who were treatment-naïve had a higher BCVA score at baseline. At 12 months, change in BCVA from baseline to 12 months was +6.5 Early Treatment Diabetic Retinopathy letters (total population), +7.8 letters (treatment-naïve), and +5.0 letters (previously treated). Gains of ≥10 and ≥15 letters, respectively, were achieved in 38% and 24% of patients in the total population, 46% and 30% in the treatment-naïve group, and 32% and 19% in the previously treated group. The mean number of injections was 7.6 in the overall population as well as in both subgroups based on prior treatment. The proportion of patients who received 5 initial IVT-AFLs within the first 5 months was 51.9% in the treatment-naïve group and 31.4% in the previously treated group. Mean change in CRT from baseline to 12 months was –130 µm (total population), –121 µm (treatment-naïve), and –141 µm (previously treated). No new safety signals were observed. Ocular adverse events (AEs) were reported in 54.1% of patients. The most common ocular AEs were cataract (4.4%) and diabetic retinal edema (3.1%).

Results from APOLLON at 12 months are consistent with outcomes from randomized controlled trials and recent real-world evidence studies with IVT-AFL.

This 12-month interim analysis of the APOLLON study showed that IVT-AFL was associated with functional and anatomical improvements in both treatment-naïve and previously treated patients with DME in routine clinical practice in France.