Authors: Peter J. Kertes, Tom Sheidow, Geoff Williams, Mark Greve, Ivan Galic, Emmanouil Rampakakis, Marcel Lahaie

Author Disclosure Block: P.J. Kertes: Any direct financial payments including receipt of honoraria; Bayer, Novartis, Allergan, Alcon, Bausch and Lomb. Description of relationship(s); Honoraria, travel grants, research funding. Membership on advisory boards or speakers’ bureaus; Bayer, Novartis, Allergan, Alcon, Bausch and Lomb. Description of relationship(s); Advisory boards. Funded grants or clinical trials; Novartis, Bayer, Allergan, Roche. Description of relationship(s); Research funding. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Arctic Dx. Description of relationship(s); Stock ownership. T. Sheidow: Membership on advisory boards or speakers’ bureaus; Novartis, Bayer, Alcon. Description of relationship(s); Advisory board. G. Williams: Membership on advisory boards or speakers’ bureaus; Novartis, Bayer, Abbvie, Alcon. Description of relationship(s); Advisory boards. Funded grants or clinical trials; Novartis, Bayer, Alcon, Allergan. Description of relationship(s); Research funds. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; ArcticDx. Description of relationship(s); Stock ownership. M. Greve: Membership on advisory boards or speakers’ bureaus; Novartis, Bayer, Alcon. Description of relationship(s); Advisory boards. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Secure Diagnostic Imaging. Description of relationship(s); Director and shareholder. I. Galic: Any direct financial payments including receipt of honoraria; Novartis. Description of relationship(s); Honoraria. Membership on advisory boards or speakers’ bureaus; Novartis, Bayer, Alcon. Description of relationship(s); Advisory boards. E. Rampakakis: All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; JSS Medical Research. Description of relationship(s); Employee. M. Lahaie: All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Novartis. Description of relationship(s); Employee.

Abstract Body:

Purpose: Few large prospective randomized clinical studies have compared the effectiveness of a treat-and-extend (T&E) regimen to monthly dosing in neovascular age-related macular degeneration (nAMD). The purpose of this study was to assess the non-inferiority of ranibizumab using a T&E regimen to once-monthly (OM) dosing in treatment-naive nAMD patients over 36 months.
Study Design: Prospective, randomized, open-label, multicenter, post-authorization, non-inferiority trial.
Methods: Ranibizumab was prescribed at the physician’s discretion according to the product monograph. Patients randomized 1:1 to the OM or T&E regimen were observed to assess best-corrected visual acuity (BCVA) and ranibizumab injection frequency. This analysis describes baseline characteristics, BCVA scores, and injection frequency at 24 months.

Results: The study was approved by all participating Research Ethics Boards. 580 patients (287 T&E: 293 OM) were randomized and 461 (235 T&E: 226 OM) had completed 24 months of follow-up. Most patients (60.3%) were female and the mean age was 78.8 years. A total of 130 (22.4%) patients (19.5% T&E; 25.3% OM) discontinued early, primarily due to withdrawal of consent (6.3% T&E; 8.2% OM). Baseline BCVA and disease characteristics were comparable between groups. At Month 24, an average of 17.6 (T&E) and 23.6 (OM) injections had been administered and BCVA improvement was comparable between groups with mean (SD) increases of 6.8 (14.1) and 6.0 (12.7) letters, respectively. BCVA non-inferiority was demonstrated with statistical significance at Month 12 (previously reported-primary outcome) and although BCVA with T&E was generally better than OM at Month 24, statistically significant superiority was not achieved (95% CI: -3.35, 1.61). Gains of ≥10 and ≥15 ETDRS letters were seen in 42.9% and 25.5% of T&E patients and 36.7% and 23.5% of OM patients, respectively; losses of >10 letters were similar between groups. In the T&E regimen, the interval between injections was extended to ≥8 weeks in 73.7% of patients and to the 12-week maximum in 43.1% of patients at 24-months, for a mean (SD) interval extension of 9.3 (2.8) weeks.

Conclusions: After 24 months, a T&E treatment regimen results in clinically meaningful improvement in BCVA with fewer injections and fewer visits compared to monthly ranibizumab administration in treatment-naïve nAMD patients.