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Efficacité du traitement par aflibercept dans l’œdème maculaire diabétique : étude de vraie vie

Diabetic macular edema (DME) is the leading cause of blindness in diabetic patients. Pivotal studies have demonstrated the efficacy of aflibercept intravitreal injections (IVI) on DME. Our main purpose was to assess the efficacy and safety of aflibercept in treatment naive patients with diabetic macular edema in a real life setting.

We conducted a retrospective, bi-center study including all consecutive naïve patients diagnosed for DME and treated with aflibercept. The mandatory regimen of treatment was 5 monthly injections followed by bimonthly IVI. Our primary endpoint was the mean change in best-corrected visual acuity (BCVA) between baseline and month 12 of follow-up.

We included 25 eyes of 21 patients. BCVA improved from baseline 61+/-11.7 (30-84) letters until 70.3+/-8.4 (47-85) letters at M6 and 72.6+/-10.3(47-85) letters at M12 after a mean of 6.84 IVI over the 12 first months representing a mean variation of +11.56 letters at M12. 32% gained more than 15 letters and 40% more than 10 letters at M12. 76% of eyes reached the threshold of 70 letters at M12. At baseline the mean CRT was 392+/-61 (304-578) µm and decreased to 288+/-61 (165-466) µm at M6 and 285+/-56 (165-407) at M12 with a mean variation of - 104µm at M6 and - 107µm at M12. 60% of eyes at M12 have completely resolved their edema and reached a flat retina. 

The efficacy and safety of aflibercept have been assessed on DME in numerous pivotal studies. There are some discrepancies between the results obtained in “real-life” settings and those of pivotal studies, due to a lower observance of appointments and treatments.

We confirmed the significant improvement of functional and anatomical outcomes over a treatment by aflibercept in DME among treatment naïve patients in a real-life setting over a follow-up of 12 months.