Treatment switch from aflibercept to ranibizumab pre-filled syringe in Canadian DME patients in a real-world setting: The PRECISE study

Abstract

Purpose : PRECISE is the first study to evaluate treatment outcomes in patients having neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) with an inadequate response to aflibercept (AFL) who were switched to ranibizumab pre-filled syringe (RBZ-PFS) in a routine clinical setting. There are limited data from real-world on treatment switch in patients showing inadequate response to ongoing AFL and thus far, there is no report on treatment switch exclusively to RBZ-PFS. Here, data of currently enrolled patients with DME are presented.

Methods : PRECISE is an observational, multicenter, real-world switch study in prior AFL-treated Canadian patients with nAMD and DME. Eligible patients, aged ≥18 years, who received ≥3 AFL injections, were switched to RBZ-PFS based on clinician’s discretion and treated as per the product label. Primary endpoint is the mean change in central retinal thickness from baseline to Day 90. Secondary endpoints include best-corrected visual acuity change, treatment regimen and safety. The study aims to enroll ~396 eyes (nAMD/DME=320/76) from 15 clinical centers across Canada.

Results : Amongst patients with DME, 8.6% and 91.4% had Type 1 and Type 2 diabetes, respectively, with 91.4% on medication. Median time since diagnosis to treatment switch to RBZ-PFS was 2.8 years in DME cohorts. Prior to study entry, median number of treatments with any anti-VEGF were 21/13 and AFL injections were 18/10 in the DME cohort. Key reasons for treatment switch in the DME patients were (i) lack of response to treatment (persistent fluid: 80.0%, loss of vision: 2.9%, unsatisfactory vision gains: 2.9%); (ii) unable to extend dosing (2.9%); (iii) safety concerns (ocular: 2.9%; systemic: 0%), and (iv) other (5.7%). Other baseline characteristics of switched patients and preliminary treatment outcomes will be presented.

Conclusions : Real-world evidence from the PRECISE study provides useful information that the key reason for treatment switch was lack of response to AFL treatment, primarily due to presence of fluid in the macula. Results from our study will further our current understanding and enhance routine clinical care of these patients.

This is a 2021 ARVO Annual Meeting abstract.