The MATE study: Treating neovascular age- related Macular degeneration with Aflibercept: a pilot, 24 month randomised controlled trial comparing standard care with individualised Treat and Extend regimen

Abstract

Purpose : Numerous treatment regimens have been described in the literature for anti-vascular endothelial growth factors i.e. monthly, bimonthly, pro re nata or Treat and Extend(T&E). T&E is a proactive, individualised treatment regime which uses the initial phases of a regimen to find an optimal dosing frequency suitable for an individual.

Methods : MATE is a prospective, pilot, multicentre randomised controlled trial running in 6 NHS ophthalmology departments across UK. 40 patients have been randomised to receive either standard care(SC)* or T&E. Baseline demographics, mean(SD) visual acuity(VA), central retinal thickness(CRT), change from baseline over 12months, number of treatments and visits over 1 year are the secondary outcomes. In keeping with good practice in pilot studies, significance testing has not been done. One patient withdrew after baseline and another with less than 12 months follow up, both in SC arm were excluded from analysis.

Results : Both groups are comparable with respect to age and gender with a female preponderance. In SC arm, mean baseline VA is 60.7(SD12.5) ETDRS letters, improving to 65.7(SD15) at the end of induction phase and returning to baseline value of 61(SD21.4)* at 12months with a mean of 7.9 treatments and 7.9 visits per patient. Mean Central Retinal Thickness (CRT) at baseline is 418(SD134) microns, decreasing to 298(SD77)*at the end of one year. In T&E arm, mean baseline VA is 63.7(SD9.9) ETDRS letters at baseline improving to 71.9(SD11.5) letters at the end of induction phase and maintaining the gain at 71.1(SD13.6) letters at 12 months. The mean number of treatments and visits are 9(SD 2) per patient and the mean treatment interval is 9(SD 3) weeks, with 50% of patients extending to 9 to 12 weeks. The mean baseline CRT is 412(SD112) microns, decreases to 259(SD 58) at the end of one year.
Figure legend: The change from baseline in VA and CRT in both arms is shown in figure 1 and 2 respectively. (n=20 at all time points in the T&E arm; SC arm *denotes n = 18 at all time points except at 12 months, n=16)

Conclusions : Both arms show initial VA gains, which is maintained at the end of one year in the T&E arm. This is achieved with one additional treatment compared to the SC arm.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.