Background <p>To evaluate treatment intervals at 12/24 months following initiation of anti-VEGF therapy and to characterise the clinical profile of neovascular AMD (nAMD) patients achieving extended treatment intervals (≥12 and ≥16 weeks).</p> Methods <p>National, retrospective, real-world study using data from the validated web-based Fight Retinal Blindness (FRB!) registry. Treatment-naive nAMD eyes managed with approved first-generation intravitreal VEGF inhibitors (ranibizumab, aflibercept 2 mg) and followed for at least 12 months were included. A subanalysis was conducted on eyes receiving a number of injections within range of a treat and extend (TAE) regimen at 12 and 24 months.</p> Results <p>A total number of 1278/557 treatment-naïve nAMD eyes within the TAE range category completed the required follow up at 12/24 months. At 12 months, 39.3% of eyes remained on ≤Q8W, 22.5% &gt;Q8W- &lt; Q12W, 29.1% ≥Q12W- &lt; Q16 and 9.1% ≥Q16W. At 24 months, the distribution was 35.4%, 17.6%, 28.3% and 18.7%, respectively. Mean VA change was not significantly different between groups at both 12 months (≤ Q8W: +4.7, Q8-Q12: +3.5, Q12-Q16: +6.1, ≥Q16W: +4.8 letters) and 24 months (≤Q8W: +5.8, Q8-Q12: +3.7, Q12-Q16: +4.1, ≥Q16W: +3 letters). The percentage of visits with active lesions was similar across groups at both time points, indicating consistent disease control.</p> Conclusions <p>Despite receiving a number of injections within a TAE range, a substantial proportion of eyes failed to achieve extended treatment intervals at 12 and 24 months (61.8% and 52.9%, respectively). These results underscore the significant unmet therapeutic need in the management of nAMD with currently approved first-generation anti-VEGF agents.</p>

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Treatment intervals with first-generation anti-vascular endothelial growth factor drugs: evaluating the unmet need in a real-world neovascular age-related macular degeneration national database

  • Javier Zarranz-Ventura,
  • Gonzaga Garay-Aramburu,
  • Pilar Calvo,
  • Miguel Angel Zapata,
  • Carolina Arruabarrena,
  • Pablo Arnáiz,
  • Paula García-Lunar,
  • Laura Sararols-Ramsay,
  • Javier Zarranz-Ventura,
  • Ruben Martin-Pinardel,
  • Marc Figueras-Roca,
  • Aina Moll-Udina,
  • Jordi Izquierdo-Serra,
  • Alba Serrano,
  • Jose Grau,
  • Carolina Bernal-Morales,
  • Sofia Batllé-Ferrando,
  • Sonia Marias-Perez,
  • Socorro Alforja,
  • Ricardo P. Casaroli-Marano,
  • Gabriel Londoño,
  • Maximiliano Olivera,
  • Alba Gomez,
  • Karim Bañon,
  • Cynthia Rethati,
  • Rafael Montejano-Milner,
  • Gabriel Liaño-Sanz Díez de Ulzurrun,
  • Miguel Angel Zapata,
  • Helena Brosa,
  • Laura Sánchez-Vela,
  • Marta Garrido,
  • José García-Arumí,
  • Ana Fernández-Hortelano,
  • Jesús Zarallo-Gallardo,
  • Rosario Cobo-Soriano,
  • Inmaculada Lozano-Escobar,
  • Paula Moreno-Martín,
  • Pilar Calvo,
  • Jorge Sánchez,
  • Martín Puzo,
  • María Pilar Ruiz-Del-Tiempo,
  • Oscar Ruiz-Moreno,
  • Gonzaga Garay-Aramburu,
  • Maria Teresa Arrazola Berrizbeitia,
  • Arantza Larrauri-Arana,
  • Angela Gómez-Moreno,
  • David Rodríguez-Feijoo,
  • Enrique Diaz-de-Durana-Santa-Coloma,
  • Maialen Aldazabal-Echeveste,
  • Zuriñe del-Barrio-Lopez-de-Ipiña,
  • Irene Herrero-Díaz,
  • Maximino José Abraldes López-Veiga,
  • María Lidia Gómez Conde,
  • María José Rodríguez-Cid,
  • María Isabel Fernández Rodríguez,
  • Pablo Fernández Varela,
  • Jacobo González Guijarro,
  • Muxima Acebes García,
  • Sonia Aparicio Sanchís,
  • Jonathan Cacelliere Fernández,
  • Marta Belmonte Grau,
  • Marta S. Figueroa,
  • Esther Ciancas,
  • Julio José Gonzalez-López,
  • Carles Barnes,
  • Esther Cilveti,
  • Stefani Carrillo,
  • Lucia Miguel-Escuder,
  • Jose Mª Ruiz Moreno,
  • Rocío Vega-González,
  • María García Zamora,
  • Ignacio Flores-Moreno,
  • Eva Salinas Martínez,
  • Francisco Javier Lavid de los Mozos,
  • Alfredo García-Layana,
  • Manuel Saenz de Viteri,
  • Elena Alonso,
  • Patricia Fernandez-Robredo,
  • Sergio Recalde,
  • Jose Juan Escobar-Barranco,
  • Manel Fernandez-Bonet,
  • Begoña Pina-Marín,
  • Xavier Valldeperas,
  • Laura Broc-Iturralde,
  • Ferran Vilaplana Mira,
  • Sandra Gómez Sánchez,
  • Pamela Campos Figueroa,
  • Lluis Arias-Barquet,
  • Estefanía Cobos,
  • Daniel Lorenzo Parra,
  • Carmen A. Rodríguez-Fernández,
  • Francisco Javier Ascaso-Puyuelo,
  • Ana Honrubia Grijalbo,
  • Ana Boned Murillo,
  • María Dolores Díaz Barreda,
  • Guillermo Pérez Rivasés,
  • Ismael Bakkali El Bakkali,
  • Nuria Oliver,
  • Nerea Castro Casal,
  • Cristóbal Quintero González,
  • Sara Rubio Cid,
  • Daniel Velázquez-Villoria,
  • Cesar Azrak Haskour,
  • Alvaro Piñero Sánchez,
  • Roberto Gallego-Pinazo,
  • Marta Cholbi,
  • Rosa Dolz-Marco,
  • Mónica Asencio Duran,
  • Nélida Muñoz Sanz,
  • Ester Carreño,
  • Nestor Ventura,
  • Luis J. Castillón Torre,
  • Pablo Catalán Muñoz,
  • María Eugenia Tena Sempere,
  • María de Fátima Álvarez Gil,
  • Purificación Piñas García,
  • María Eugenia Mantrana Bermejo,
  • Saturnino Gismero-Moreno,
  • Ana Chinchurreta Capote,
  • Ana Belén González Escobar,
  • Juan Angel Moreno Gutierrez,
  • Pablo Carnota-Méndez,
  • Carlos Méndez-Vázquez,
  • Carlos Torres-Borrego,
  • Francisco Rodríguez Hurtado,
  • Jesús Ramón García-Martínez,
  • Alejandro Fonollosa Calduch,
  • Jose Antonio Sanchez,
  • Lucia Galletero,
  • Alba Parrado-Carrillo,
  • Isaac Alarcón-Valero,
  • Teresa Diago,
  • Adrián Hernández-Martínez,
  • Jesús Pareja Esteban,
  • María Angeles Espiñeira Periñan,
  • Mariano Rodríguez-Maqueda,
  • Magdalena Sotomayor Toribio,
  • Marta Rodríguez-Núñez,
  • Ana Campo Gesto

摘要

Background

To evaluate treatment intervals at 12/24 months following initiation of anti-VEGF therapy and to characterise the clinical profile of neovascular AMD (nAMD) patients achieving extended treatment intervals (≥12 and ≥16 weeks).

Methods

National, retrospective, real-world study using data from the validated web-based Fight Retinal Blindness (FRB!) registry. Treatment-naive nAMD eyes managed with approved first-generation intravitreal VEGF inhibitors (ranibizumab, aflibercept 2 mg) and followed for at least 12 months were included. A subanalysis was conducted on eyes receiving a number of injections within range of a treat and extend (TAE) regimen at 12 and 24 months.

Results

A total number of 1278/557 treatment-naïve nAMD eyes within the TAE range category completed the required follow up at 12/24 months. At 12 months, 39.3% of eyes remained on ≤Q8W, 22.5% >Q8W- < Q12W, 29.1% ≥Q12W- < Q16 and 9.1% ≥Q16W. At 24 months, the distribution was 35.4%, 17.6%, 28.3% and 18.7%, respectively. Mean VA change was not significantly different between groups at both 12 months (≤ Q8W: +4.7, Q8-Q12: +3.5, Q12-Q16: +6.1, ≥Q16W: +4.8 letters) and 24 months (≤Q8W: +5.8, Q8-Q12: +3.7, Q12-Q16: +4.1, ≥Q16W: +3 letters). The percentage of visits with active lesions was similar across groups at both time points, indicating consistent disease control.

Conclusions

Despite receiving a number of injections within a TAE range, a substantial proportion of eyes failed to achieve extended treatment intervals at 12 and 24 months (61.8% and 52.9%, respectively). These results underscore the significant unmet therapeutic need in the management of nAMD with currently approved first-generation anti-VEGF agents.