Efficacy and safety of intravitreal aflibercept (Eylea) for diabetic macular oedema: 18- month experience

Session Details

Session Title: Free Paper Session 16: Vascular Diseases & Diabetic Retinopathy IV

Session Date/Time: Friday 08/09/2017 | 16:30-18:00

Paper Time: 17:48

Venue: Room 114

First Author: : A.Higham UK

Co Author(s): :    M. Tahir   K. Gala   G. Verroiopoulos                       

Abstract Details

Purpose:

The National Institute for Health and Care Excellence (NICE) has recommended the intravitreal anti- vascular endothelial growth factor (VEGF), Aflibercept (Eylea) for treating diabetic macular oedema (DMO) since July 2015. Any patient with visual impairment associated with DMO with a central retinal thickness (CRT) over 400 microns is eligible for treatment. Results from benchmark multicentre clinic trials (VISTA and VIVID) were compared to those from our National Health Service (NHS) hospital to evaluate the ‘real life’ efficacy and safety of Eylea in DMO management.

Setting:

Patients receiving intravitreal Eylea for DMO were included from an outpatient NHS ophthalmology unit in Windsor, United Kingdom.

Methods:

We included all patients who had received intravitreal Eylea for DMO between July 2015 and February 2017. The treatment regime was in line with the NICE guidelines (5 monthly injections, then 2 monthly injections if required and then individualized treatment). Data were collected from electronic Medisoft notes. Details of best corrected visual acuity (BCVA), central retinal thickness (CRT) and complications were obtained from patient notes at baseline and after each injection. CRT values were taken as the highest value in the foveal area on ocular coherence tomography. All visual acuities were recorded as letter score. Data was entered using Microsoft Excel and analysed using Excel and SPSS version 24.

Results:

We reviewed 83 patients, 61 men (99 eyes). Patients had a mean number of 4.5 (range 1-9) injections during this period. Most patients were converted to Eylea as a result of limited improvement with previous anti- VEGF or Ozurdex® treatment; 55 patients had previously been treated with Lucentis, 7 a combination of Lucentis, Avastin and Ozurdex®. 60 patients had previous macular laser. At 5 months, there was a significant improvement in BCVA and reduction in CRT (p<0.005, p<0.005) with a mean improvement of 5 letters, and a mean reduction of 87microns CRT. Looking at patients were naïve to anti-VEGF or Ozurdex® treatment, there was a 6 letter improvement at 5 months with 113micron decrease in CRT. Of those patients who were followed up for 52 weeks, the mean letter gain from baseline was 4, with a 109micron reduction in CRT. 14% had a >15 letter improvement. At 52 weeks, in those naïve to other anti-VEGFs or Ozurdex®, the mean BCVA improvement was 8 letters with a 109micron reduction in CRT. During this audit we had 1 case of endophthalmitis and two patients had strokes. 14 patients discontinued Eylea treatment after lack of response or patient choice.

Conclusions:

Within this setting of routine clinical practice and a real life follow up schedule there was an improvement both anatomically and functionally for those patients treated with Eylea for DMO. Patients who were naïve to other anti-VEGFs or Ozurdex® treatments had greater improvements in outcomes. However, our outcomes were inferior to those in VISTA and VIVID whose results at 52 weeks saw a 12.5 and 10.5 BCVA letter gain, respectively. This could be explained by our wider inclusion of patients with underlying conditions that may limit improvement, e.g. epiretinal membranes, vitreomacular traction and proliferative diabetic retinopathy. Overall, Eylea is a safe and efficacious treatment for DMO in our cohort.

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