Authors:

Michel Giunta, Ananda Kalevar, Pierre Trottier, Louis Caron, Sohel Somani, Raman Tuli, Ghassan Cordahi, Joanne Gavalakis, Eser Adiguzel.

Author Disclosure Block:

M. Giunta: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Abbott, Alcon, Novartis. Any direct financial payments including receipt of honoraria; Description of relationship(s); Advisory Board. Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Abbott, Alcon, Bausch & Lomb, Bayer AG, Novartis. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Allergan, Bayer AG, Chengdu Kanghong Biotechnology, F. Hoffmann-La Roche, Novartis. A. Kalevar: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Alcon, Novartis, Bayer, Allergan. P. Trottier: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Allergan, Alcon, Bausch&Lomb, Bayer, Novartis, Thea Laboratories. Any direct financial payments including receipt of honoraria; Description of relationship(s); Consultant. L. Caron: Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Novartis. S. Somani: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Bayer. Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Novartis. R. Tuli: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Novartis, Bayer. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Novartis, Roche, Apelis. G. Cordahi: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Allergan, Alcon, Bausch and Lomb, Bayer, Novartis. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Allergan, Bayer, Novartis. J. Gavalakis: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Novartis. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. E. Adiguzel: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Novartis. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee.

Abstract Body:

Purpose: PRECISE is the first study to evaluate treatment outcomes in diabetic macular edema (DME) patients with an inadequate response to ongoing aflibercept (AFL) treatment who were switched to ranibizumab pre-filled syringe (RBZ-PFS) in a real-world setting in Canada. Here, we present the preliminary outcomes from the PRECISE study.
Study Design: PRECISE is a prospective, observational, multicenter, real-world study.
Methods: Eligible consenting patients, ≥18 years, who received ≥3 AFL intravitreal injections for DME, who were switched to RBZ-PFS based on clinician’s discretion and treated as per the product label were enrolled into the study from 15 clinical centers across Canada. Primary endpoint was mean change from baseline to day 90 in central retinal thickness (CRT). Secondary endpoints included change in best-corrected visual acuity (BCVA), reasons for treatment switch, functional outcomes, treatment injection interval, and safety. The study aimed to enroll 76 eyes with DME.
Results: Preliminary results analyzed thus far are presented below.At baseline, mean(SD) CRT was 357.4(87.6)µm and mean(SD) BCVA was 63.8(12.9) ETDRS letters; 85.7% with presence of macular fluid (96.7% intraretinal fluid [IRF]; 3.3% IRF and sub-retinal fluid) with no pigment epithelial detachments.Median time since diagnosis to first RBZ-PFS was 2.8 years. Prior to study entry, patients received a median of 13 injections of any anti-VEGF, with median of 10 AFL injections. Median time from last AFL to first RBZ-PFS was 1.4 months. Key reasons for treatment switch were lack of response to treatment (80.0% persistent fluid, 2.9% loss of vision, 2.9% unsatisfactory vision gains), unable to extend dosing (2.9%), ocular safety concerns (2.9%), and other (5.7%). Preliminary results of study completers demonstrated CRT reduction (-28.5um; p=0.026), with 82.4% with continued presence of macular fluid, and maintenance of visual acuity (+1.8 letters; p=0.210) at Day 90 post-switch, with average treatment interval of 4.8 weeks.Incidence of adverse events/serious adverse events were low, with no new identified safety signals.
Conclusions: Real-world evidence from the PRECISE study provides useful information on the baseline characteristics of DME patients who required the treatment switch from AFL to RZB-PFS. Data from enrolled patients analyzed thus far showed that the key reason for treatment switch to RBZ-PFS was lack of response to aflibercept treatment, primarily due to presence of fluid in the macula. Preliminary results from completers demonstrated a reduction in CRT, with maintenance of visual acuity and safety. Final results from our study will further our current understanding and enhance routine clinical care of DME patients.