Real world outcomes of aflibercept (Eylea) for diabetic macular edema: Does fixed dose protocol work better than individualised treatment?

Session Details

Session Title: Free Paper Session 23: Vascular Diseases & Diabetic Retinopathy VI

Session Date/Time: Sunday 10/09/2017 | 08:00-09:30

Paper Time: 08:18

Venue: Room 120

First Author: : P.Tyagi UK

Co Author(s): :    A. Ionean   C. Santiago                          

Abstract Details

Purpose:

To determine the clinical outcomes of intravitreal Aflibercept in diabetic macular oedema (DMO) at one year in treatment Naïve patients and those Switched from other anti-VEGF agents and to assess the results of fixed dose protocol regime and individualised treatment regime in each group.

Setting:

Aberdeen Royal Infirmary, Aberdeen, Scotland, UK.

Methods:

A single centre retrospective study over 24 months (December 2014 to November 2016) period. The data was collected from electronic medical records (Medisoft, UK). Two cohorts of patients were identified, the Treatment naive group who had received no previous anti-VEGF therapy and the Switch group i.e. those switched from other anti-VEGF agents including Ranibizumab and Bevacizumab to Aflibercept. Each cohort was further divided into two sub-groups: 1) those that followed the Scottish medical consortium (SMC) recommended fixed dose protocol, comprising of initial loading with 5 X 1-monthly followed by 3 x 2-monthly aflibercept intravitreal injections in year one of treatment and 2) those that did not follow the above protocol and had individualised treatment regime receiving variable number of injections in year one based on clinical response of DMO. Best corrected visual acuity (BCVA) in ETDRS letters and central macular thickness (CMT) in micrometers (mcs) were assessed at baseline (M0) and 12 months (M12) post treatment as mean (SD). Patients who completed 12 months follow up were included in the study. Those patients that had other retinal diseases, vitreous haemorrhage due to proliferative diabetic retinopathy likely to affect visual outcomes and inadequate followup were excluded.

Results:

105 eyes received Aflibercept treatment for DMO during study period. 59 (21 Treatment-Naïve and 38 Switched from other anti-VEGF treatments) completed 12 months follow-up. The Treatment-Naïve (n=21), fixed-dose protocol sub-group (n=9) received 8 injections compared to 6.08 by the individualised treatment sub-group (n=12) in year one. With fixed dosing, the BCVA changed from 59.67 (M0) to 68.11 (M12) with gain of 8.44 letters; the CRT improved from 462.00 (M0) to 304.67 (M12) with reduction of 157 mcs. In the treatment-naïve, individualised treatment sub-group, the BCVA changed from 49.75 (M0) to 63.25 (M12) with gain of 13.50 letters; CRT changed from 560.58 (M0) to 300.91 (M12) with reduction of 275.64 mcs. The Switch group (n=38), on fixed-dose protocol (n=18) received 8 injections compared to 5.30 by individualised treatment sub-group (n=20) in year one. With fixed dosing, the BCVA changed from 58.50 (M0) to 66.56 letters (M12) with gain of 8.06 letters. The CRT improved from 531.56 (M0) to 303.22 (M12) with reduction of 228.33. In the individualised treatment sub-group, the BCVA changed from 55.35 (M0) to 59.84 (M12) with gain of 5.26 letters; the CRT changed from 517.30 (M0) to 373.50 (M12) with reduction of 143.80 mcs.

Conclusions:

Patients on individualised treatment regime with Aflibercept received less injections in first year compared to fixed-dose protocol in both treatment naive and switch groups. Both groups showed improvement in vision and reduction in CRT at one year. In our study, treatment naïve patients on individually tailored treatment regime gained more vision and achieved significant reduction in CRT after one year of treatment but started with lower mean baseline vision than those that received fixed dose. The switch group that had been previously treated with anti-VEGF injections showed a better response to fixed dosing protocol with Aflibercept both anatomically and functionally signalling the need for continuous and sustained anti-VEGF therapy to achieve good outcomes.

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