Treat-and-Extend Versus Pro re nata Regimens of Ranibizumab and Aflibercept in Neovascular Age-Related Macular Degeneration: A Comparative Study from Routine Clinical Practice

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2024年7月8日

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Eloi Debourdeau,
Helene Beylerian,
Vuong Nguyen,
Daniel Barthelmes,
Mark Gillies,
Pierre Henry Gabrielle,
Stela Vujosevic,
Louise Otoole,
Martin Puzo,
Catherine Creuzot-Garcher,
Benjamin Wolff,
Vincent Daien,
A. Cohn,
Bacchus Marsh,
N. Jaross,
R. Barry,
I. McLean,
T. Guillaumie,
A. Miri,
P. Gabrielle,
S. Tick,
A. Field,
S. Wickremasinghe,
C. Dayajeewa,
J. Wells,
A. Dunlop,
S. Young,
G. Mimoun,
R. Guymer,
P. Carnota,
R. Gallego-Pinazo,
A. García Layana,
M. Saenz-de-Viteri,
R. Ferrier,
L. Chow,
H. Steiner,
A. Amini,
J. Chen,
N. Saha,
P. Windle,
M. Gillies,
A. Hunt,
P. Beaumont,
Z. Louw,
A. Luckie,
S. Lake,
D. Qatarneh,
L. Sararols,
J. Suarez,
P. Berdoukas,
F. Viola,
R. Montejano Milner,
C. Arruabarrena,
F. Ascaso,
A. Boned Murillo,
M. Díaz,
G. Perez Rivases,
S. Alforja Castiella,
R. Casaroli-Marano,
M. Figueras-Roca,
J. Zarranz-Ventura,
S. Gismero Moreno,
A. González Escobar,
JMoreno Gutiérrez,
J. Escobar,
F. Lavid,
P. Catalán Muñoz,
M. Tena Sempere,
F. Ricci,
L. Broc Iturralde,
S. Gómez Sánchez,
G. Garay-Aramburu,
N. Munoz Sanz,
P. Calvo,
J. Sanchez,
E. Almazan Alonso,
M. Garcia Zamora,
E. Ciancas,
J. Gonzalez-Lopez,
D. Lorenzo,
M. Acebes,
S. Aparicio-Sanchis,
A. Fernández Hortelano,
A. Piñero Sánchez,
L. García García,
E. Salinas Martínez,
A. Campo Gesto,
M. Rodriguez Núñez,
L. Manning,
A. Invernizzi,
L. Castelnovo,
G. Michel,
B. Wolff,
M. Perks,
J. Arnold,
H. Cass,
L. OToole,
K. Tang,
C. Chung,
V. Daien,
G. Banerjee,
M. Morgan,
J. Game,
C. Thompson,
R. Chalasani,
M. Chilov,
A. Fung,
S. Nothling,
R. Chong,
S. Fraser-Bell,
C. Younan,
D. Louis,
P. Lockie,
J. Wong,
P. Hinchcliffe,
D. Barthelmes,
E. Diaz De Durana Santa Coloma,
G. Garay-Aramburu,
S. Vujosevic,
H. Brosa Morros,
A. Harper,
J. ODay,
C. Hooper,
Maria Jose Rodríguez Cid

摘要

Introduction

Anti-vascular endothelial growth factor (VEGF) is generally given using pro re nata or “treat-and-extend” (T&E) regimens for neovascular age-related macular degeneration (nAMD). Randomized clinical trials have reported that T&E is superior to Pro re nata (PRN), but results from clinical trials may not always be replicated in clinical practice. Real-world data comparing T&E and PRN regimens for nAMD are limited. The objective of this work was to report 24-month outcomes of PRN versus T&E regimens for ranibizumab and aflibercept to treat nAMD in routine clinical practice.

Methods

We conducted a retrospective analysis of data from a prospectively designed observational outcomes registry, the Fight Retinal Blindness! Project (FRB). Treatment-naïve eyes starting nAMD treatment with at least three injections using a T&E or PRN regimen were tracked by using the FRB. The primary outcome was the mean change in visual acuity (VA) measured by the number of letters read on a logarithm of the minimum angle of resolution chart at 2 years versus baseline. The secondary outcome was the number of injections at 2 years.

Results

From January 1, 2015 to January 31, 2019, 3313 eyes from 2948 patients with nAMD were included: 1243 eyes from 1065 patients were classified as PRN and 2070 eyes from 1935 patients started a T&E regimen. At 24 months, patients on the T&E regimen experienced significantly greater mean (95% confidence interval) improvement in VA than those on PRN (+ 4.2 [3.1, 5.2] vs. + 1.3 [0.1, 2.6] letters; p < 0.001), with more injections (14.9 standard deviation(SD) 4.3) vs. 9.8(SD 4.3); p < 0.001).

Conclusions

Eyes treated with a T&E regimen had better VA outcomes from VEGF inhibitors than eyes treated PRN. This large real-world data assessment supports previous data from randomized clinical trials that the T&E regimen delivers better outcomes than PRN.