Treatment of diabetic macular edema by ranibizumab : real-life study in a private practice in Paris

Abstract

Purpose : To assess real life efficacy and safety of ranibizumab in patients with vision loss secondary to diabetic macular edema (DME).

Methods : We conducted a retrospective study including patients with vision loss secondary to DME and treated by ranibizumab in a Parisian private practice specialized in retina diseases. For each patient, measure of the best corrected visual acuity (BCVA) on the ETDRS scale, macular OCT before and during treatment every 4 to 6 weeks were performed.
All patients received a loading dose of 3 monthly injections followed by re-treatments on an as-needed basis (PRN regimen).
The primary endpoint was the change of visual acuity (VA) at month 12.
The secondary outcomes were central retinal thickness (CRT) after the loading dose and at month 12, the macular volume (MV) and the number of intravitreal injections (IVT) during the first year of follow-up.

Results : 75 eyes of 55 consecutive patients treated since june 2010 have been included. The mean duration of DME before the first injection was 14 months. At baseline, the mean BCVA was 54.68 letters, the CRT was 479 microns with a VM of 13.3 mm³[AA1] .
At M12, the mean change of BCVA was +8 letters (L). the mean BCVA was 62,68 L (p <0.05), 26,8 % of patients had a BCVA> 70 L. The mean CRT after 3 IVT was 309.1 microns (p <0.05) with a macular volume of 11.2 mm³, and M12, mean CRT was 346.4 microns (p <0.05) and the mean MV was 11.7 mm³.
The mean number of IVT performed during the first year of follow up was 5.08.
No serious adverse event was noted.

Conclusions : Phase III studies have clearly shown the benefit of ranibizumab treatment in vision loss due to DME.
Our real-life study confirms the efficacy and safety of ranibizumab in the treatment of vision loss due to DME with a gain of 8L at one year and 5.08 IVT during the first year of treatment

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.