TY - JOUR
T1 - Treat-and-Extend Versus Pro re nata Regimens of Ranibizumab and Aflibercept in Neovascular Age-Related Macular Degeneration
T2 - A Comparative Study from Routine Clinical Practice
AU - Debourdeau, Eloi
AU - Beylerian, Helene
AU - Nguyen, Vuong
AU - Barthelmes, Daniel
AU - Gillies, Mark
AU - Gabrielle, Pierre Henry
AU - Vujosevic, Stela
AU - Otoole, Louise
AU - Puzo, Martin
AU - Creuzot-Garcher, Catherine
AU - Wolff, Benjamin
AU - Daien, Vincent
AU - the Fight Retinal Blindness! Study Group
AU - Cohn, A
AU - Jaross, N.
AU - Barry, R
AU - McLean, I
AU - Guillaumie, T.
AU - Miri, A.
AU - Gabrielle, P.
AU - Tick, S.
AU - Field, A
AU - Wickremasinghe, S.
AU - Dayajeewa, C.
AU - Wells, J
AU - Dunlop, A
AU - Young, S.
AU - Mimoun, G.
AU - Guymer, R.
AU - Carnota, P.
AU - Gallego-Pinazo, R.
AU - García Layana, A.
AU - Saenz-de-Viteri, M.
AU - Ferrier, R.
AU - Chow, L.
AU - Steiner, H.
AU - Amini, A.
AU - Chen, J.
AU - Saha, N.
AU - Windle, P.
AU - Gillies, M.
AU - Hunt, A.
AU - Beaumont, P.
AU - Louw, Z.
AU - Luckie, A.
AU - Lake, S.
AU - Qatarneh, D.
AU - Sararols, L.
AU - Suarez, J.
AU - Berdoukas, P.
AU - Viola, F.
AU - Montejano Milner, R.
AU - Arruabarrena, C.
AU - Ascaso, F.
AU - Boned Murillo, A.
AU - Díaz, M.
AU - Perez Rivases, G.
AU - Alforja Castiella, S.
AU - Casaroli-Marano, R.
AU - Figueras-Roca, M.
AU - Zarranz-Ventura, J.
AU - Gismero Moreno, S.
AU - González Escobar, A.
AU - Moreno Gutiérrez, J.
AU - Escobar, J.
AU - Lavid, F.
AU - Catalán Muñoz, P.
AU - Tena Sempere, M.
AU - Ricci, F.
AU - Broc Iturralde, L.
AU - Gómez Sánchez, S.
AU - Garay-Aramburu, G.
AU - Munoz Sanz, N.
AU - Calvo, P.
AU - Sanchez, J.
AU - Almazan Alonso, E.
AU - Garcia Zamora, M.
AU - Ciancas, E.
AU - Gonzalez-Lopez, J.
AU - Lorenzo, D.
AU - Acebes, M.
AU - Aparicio-Sanchis, S.
AU - Fernández Hortelano, A.
AU - Piñero Sánchez, A.
AU - García García, L.
AU - Salinas Martínez, E.
AU - Campo Gesto, A.
AU - Rodriguez Núñez, M.
AU - Manning, L.
AU - Invernizzi, A.
AU - Castelnovo, L.
AU - Michel, G.
AU - Wolff, B.
AU - Perks, M.
AU - Arnold, J.
AU - Cass, H.
AU - OToole, L.
AU - Tang, K.
AU - Chung, C.
AU - Daien, V.
AU - Banerjee, G.
AU - Morgan, M
AU - Game, J.
AU - Thompson, C.
AU - Chalasani, R.
AU - Chilov, M.
AU - Fung, Adrian
AU - Nothling, S.
AU - Chong, R
AU - Fraser-Bell, S.
AU - Younan, C.
AU - Louis, D
AU - Lockie, P.
AU - Wong, J
AU - Hinchcliffe, P.
AU - Barthelmes, D.
AU - Diaz De Durana Santa Coloma, E.
AU - Garay-Aramburu, G.
AU - Vujosevic, S.
AU - Brosa Morros, H.
AU - Harper, A.
AU - ODay, J.
AU - Hooper, C
AU - Rodríguez Cid, Maria Jose
PY - 2024/9
Y1 - 2024/9
N2 - 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.
AB - 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.
KW - Intraocular injection
KW - Neovascular AMD
KW - Pro re nata
KW - Treat-and-extend
UR - http://www.scopus.com/inward/record.url?scp=85202464411&partnerID=8YFLogxK
U2 - 10.1007/s40123-024-00983-2
DO - 10.1007/s40123-024-00983-2
M3 - Article
AN - SCOPUS:85202464411
SN - 2193-8245
VL - 13
SP - 2343
EP - 2355
JO - Ophthalmology and Therapy
JF - Ophthalmology and Therapy
IS - 9
ER -