Creation of a neovascular age-related macular degeneration national database using a web-based platform: Fight Retinal Blindness Spain. Report 1: Visual outcomes.


Journal

Clinical & experimental ophthalmology
ISSN: 1442-9071
Titre abrégé: Clin Exp Ophthalmol
Pays: Australia
ID NLM: 100896531

Informations de publication

Date de publication:
04 2022
Historique:
revised: 14 01 2022
received: 10 11 2021
accepted: 22 01 2022
pubmed: 3 2 2022
medline: 6 4 2022
entrez: 2 2 2022
Statut: ppublish

Résumé

To study the visual outcomes of neovascular AMD (nAMD) treated with anti-vascular endothelial growth factor (VEGF) drugs at national level. Multicenter national database of nAMD eyes treated with anti-VEGF intravitreal injections (ranibizumab, aflibercept, bevacizumab) in fixed bimonthly (FB) or treat-and-extend (TAE) regimens. Demographics, visual acuity (VA) in logarithm of the minimum angle of resolution (logMAR) ETDRS letters at baseline and subsequent visits, number of injections and visits data were collected using a validated web-based tool (Fight Retinal Blindness!). 1273 eyes (1014 patients) were included, 971 treatment naïve (TN) and 302 previously treated (PT). Baseline VA (mean ± SD) was 57.5 (±19.5) and 62.2 (±17) (p > 0.001), and 24 months final VA was 60.4 (±21.2) and 58.8 (±21.1) (p = 0.326), respectively. Mean VA change at 12/24 months was +4.2/+2.9 letters in TN eyes and +0.1/-3.4 letters in PT eyes (p < 0.001/p < 0.001). The percentage of ≥15 letters gainers/losers at 24 months was 24.8%/14.5% in TN, and 10.3%/15.7% in PT eyes. The median number of injections/visits at 12 months was 7/9 in TN and 6/8 in PT (p = 0.002/p < 0.001) and at 24 months was 11/16 in TN and 11/14 in PT (p = 0.329/p < 0.001). Study drugs included ranibizumab (39.5%), aflibercept (41.2%) and bevacizumab (19.3%). Independent, large-scale national audits are feasible if committed health care professionals are provided with efficient information technology systems to do them. The results described here represent an adequate measurement of the quality of care delivered nationwide and benchmark the clinical management of nAMD at a country level compared to other real-world international cohorts.

Sections du résumé

BACKGROUND
To study the visual outcomes of neovascular AMD (nAMD) treated with anti-vascular endothelial growth factor (VEGF) drugs at national level.
METHODS
Multicenter national database of nAMD eyes treated with anti-VEGF intravitreal injections (ranibizumab, aflibercept, bevacizumab) in fixed bimonthly (FB) or treat-and-extend (TAE) regimens. Demographics, visual acuity (VA) in logarithm of the minimum angle of resolution (logMAR) ETDRS letters at baseline and subsequent visits, number of injections and visits data were collected using a validated web-based tool (Fight Retinal Blindness!).
RESULTS
1273 eyes (1014 patients) were included, 971 treatment naïve (TN) and 302 previously treated (PT). Baseline VA (mean ± SD) was 57.5 (±19.5) and 62.2 (±17) (p > 0.001), and 24 months final VA was 60.4 (±21.2) and 58.8 (±21.1) (p = 0.326), respectively. Mean VA change at 12/24 months was +4.2/+2.9 letters in TN eyes and +0.1/-3.4 letters in PT eyes (p < 0.001/p < 0.001). The percentage of ≥15 letters gainers/losers at 24 months was 24.8%/14.5% in TN, and 10.3%/15.7% in PT eyes. The median number of injections/visits at 12 months was 7/9 in TN and 6/8 in PT (p = 0.002/p < 0.001) and at 24 months was 11/16 in TN and 11/14 in PT (p = 0.329/p < 0.001). Study drugs included ranibizumab (39.5%), aflibercept (41.2%) and bevacizumab (19.3%).
CONCLUSION
Independent, large-scale national audits are feasible if committed health care professionals are provided with efficient information technology systems to do them. The results described here represent an adequate measurement of the quality of care delivered nationwide and benchmark the clinical management of nAMD at a country level compared to other real-world international cohorts.

Identifiants

pubmed: 35106882
doi: 10.1111/ceo.14054
doi:

Substances chimiques

Angiogenesis Inhibitors 0
Recombinant Fusion Proteins 0
Vascular Endothelial Growth Factor A 0
Receptors, Vascular Endothelial Growth Factor EC 2.7.10.1
Ranibizumab ZL1R02VT79

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

312-324

Investigateurs

Javier Zarranz Ventura (JZ)
Alba Parrado Carrillo (AP)
Marc Figueras Roca (MF)
Aina Moll Udina (AM)
Jordi Izquierdo Serra (JI)
Carolina Bernal Morales (CB)
Socorro Alforja (S)
Ricardo P Casaroli Marano (RP)
Laura Sararols Ramsay (LS)
Gabriel Londoño (G)
Maximiliano Olivera (M)
Karim Bañon (K)
Cynthia Rethati (C)
Pilar Calvo (P)
Jorge Sánchez (J)
Martín Puzo (M)
Oscar Ruiz Moreno (OR)
Gonzaga Garay Aramburu (GG)
Arantza Larrauri Arana (AL)
Angela Gómez Moreno (AG)
David Rodríguez Feijoo (DR)
Enrique Diaz de Durana Santa Coloma (ED)
Maialen Aldazabal Echeveste (MA)
Zuriñe Del Barrio Lopez de Ipiña (Z)
Irene Herrero Díaz (IH)
José García Arumí (JG)
Helena Brosa (H)
Laura Sánchez Vela (LS)
Miguel Angel Zapata (MA)
Carolina Arruabarrena (C)
Rafael Montejano Milner (RM)
Fernando de Aragón (F)
Maximino José Abraldes López Veiga (MJAL)
María Lidia (M)
Gómez Conde (G)
María José Rodríguez Cid (MJR)
María Isabel Fernández Rodríguez (MIF)
Pablo Almuiña (P)
Varela Ana Fernández Hortelano (VAF)
Jesús Zarallo Gallardo (JZ)
Rosario Cobo Soriano (RC)
Inmaculada Lozano Escobar (IL)
Paula Moreno Martín (PM)
Jose Mª Ruiz Moreno (JMR)
Rocío Vega González (RV)
María García Zamora (MG)
Ignacio Flores Moreno Xavier Valldeperas (IFMX)
Laura Broc Iturralde (LB)
Ferran Vilaplana Mira (FV)
Sandra Gómez Sánchez (SG)
Pamela Campos Figueroa (PC)
Jose Juan Escobar Barranco (JJE)
Manel Fernandez Bonet (MF)
Begoña Pina Marín (BP)
Eva Salinas (E)
Martínez Jacobo González Guijarro (MJG)
Muxima Acebes García (MA)
Sonia Aparicio Sanchís (SA)
Jonathan Cacelliere Fernández (JC)
Marta Belmonte Grau (MB)
Francisco Javier Ascaso Puyuelo (FJA)
Ana Honrubia Grijalbo (AH)
Ana Boned Murillo (AB)
María Dolores (M)
Díaz Barreda (D)
Guillermo Pérez Rivasés (GP)
Ismael Bakkali El Bakkali (IB)
Roberto Gallego Pinazo (RG)
Marta Cholbi (M)
Rosa Dolz Marco (RD)
Marta S Figueroa (MS)
Esther Ciancas (E)
Julio José (J)
Gonzalez López (G)
Cesar Azrak Haskour (CA)
Alvaro Piñero Sánchez (AP)
Nélida Muñoz Sanz (NM)
Ester Carreño (E)
Nestor Ventura (N)
Pablo Carnota Méndez (PC)
Carlos Méndez Vázquez (CM)
Carlos Torres Borrego (CT)
Daniel Velázquez Villoria (DV)
Alfredo García Layana (AG)
Manuel Saenz de Viteri (MS)
Elena Alonso (E)
Luis J Castillón Torre (LJ)
Pablo Catalán Muñoz (PC)
María Eugenia Tena Sempere (MET)
María de Fátima Álvarez Gil (M)
Purificación Piñas García (PP)
María Eugenia (M)
Mantrana Bermejo (M)
Francisco Javier (F)
Lavid de Los Mozos (L)
Mónica Asencio Duran (MA)
Lluis Arias Barquet (LA)
Estefanía Cobos Martín (EC)
Daniel Lorenzo Parra (DL)
Marta Rodríguez Núñez (MR)
Ana Campo Gesto (AC)
Jesús Pareja Esteban (JP)
María Del Pilar Ruiz Del Tiempo (MD)
Mariano Rodríguez Maqueda (MR)
María Angeles (M)
Espiñeira Periñan (E)
Magdalena Sotomayor Toribio (MS)

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2022 The Authors. Clinical & Experimental Ophthalmology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Ophthalmologists.

Références

Mehta H, Tufail A, Daien V, et al. Real-world outcomes in patients with neovascular age-related macular degeneration treated with intravitreal vascular endothelial growth factor inhibitors. Prog Retin Eye Res. 2018;65(September 2017):127-146.
Schmidt-Erfurth U, Chong V, Loewenstein A, et al. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014;98(9):1144-1167.
Kertes PJ, Galic IJ, Greve M, et al. Efficacy of a treat-and-extend regimen with ranibizumab in patients with neovascular age-related macular disease. JAMA Ophthalmol. 2020;138(3):244.
López Gálvez MI, Arias Barquet L, Figueroa MS, et al. Bimonthly, treat-and-extend and as-needed ranibizumab in naïve neovascular age-related macular degeneration patients: 12-month outcomes of a randomized study. Acta Ophthalmol. 2020;98(7):e820-e829. https://orcid.org/10.1111/aos.14399
Writing Committee for the UK Age-Related Macular Degeneration EMR Users Group. The neovascular age-related macular degeneration database: multicenter study of 92 976 ranibizumab injections: report 1: visual acuity. Ophthalmology. 2014;121(5):1092-1101.
Zarranz-Ventura J, Liew G, Johnston RL, et al. The neovascular age-related macular degeneration database: report 2: incidence, management, and visual outcomes of second treated eyes. Ophthalmology. 2014;121(10):1966-1975.
Almuhtaseb H, Johnston RL, Talks JS, Lotery AJ. Second-year visual acuity outcomes of nAMD patients treated with aflibercept: data analysis from the UK aflibercept users group. Eye. 2017;31(11):1582-1588.
Rao P, Lum F, Wood K, et al. Real-world vision in age-related macular degeneration patients treated with single anti-VEGF drug type for 1 year in the IRIS registry. Ophthalmology. 2018;125(4):522-528.
Barthelmes D, Nguyen V, Daien V, et al. Two year outcomes of ‘treat and extend’ Intravitreal therapy using aflibercept preferentially for neovascular age-related macular degeneration. Retina. 2018;38(1):20-28.
Arnold JJ, Campain A, Barthelmes D, et al. Two-year outcomes of ‘treat and extend’ intravitreal therapy for neovascular age-related macular degeneration. Ophthalmology. 2015;122(6):1212-1219.
Liew G, Lee AY, Zarranz-Ventura J, et al. The UK neovascular AMD database report 3: inter-Centre variation in visual acuity outcomes and establishing real-world measures of care. Eye. 2016;30(11):1462-1468.
Madhusudhana KC, Lee AY, Keane PA, et al. UK neovascular age-related macular degeneration database. Report 6: time to retreatment after a pause in therapy. Outcomes from 92 976 intravitreal ranibizumab injections. Br J Ophthalmol. 2016 Dec;100(12):1617-1622.
Mehta H, Hennings C, Gillies MC, Nguyen V, Campain A, Fraser-Bell S. Anti-vascular endothelial growth factor combined with intravitreal steroids for diabetic macular oedema. Cochrane Database Syst Rev. 2018;4(4):1-59.
Holz FG, Tadayoni R, Beatty S, et al. Determinants of visual acuity outcomes in eyes with neovascular AMD treated with anti-VEGF agents: an instrumental variable analysis of the AURA study. Eye. 2016;30(8):1063-1071.
Holz FG, Figueroa MS, Bandello F, et al. Ranibizumab treatment in treatment-naive neovascular age-related macular degeneration. Retina. 2020;40(9):1673-1685.
Finger RP, Wiedemann P, Blumhagen F, Pohl K, Holz FG. Treatment patterns, visual acuity and quality-of-life outcomes of the WAVE study-a noninterventional study of ranibizumab treatment for neovascular age-related macular degeneration in Germany. Acta Ophthalmol. 2013;91(6):540-546. http://dx.doi.org/10.1111/j.1755-3768.2012.02493.x
Cohen SY, Mimoun G, Oubraham H, et al. Changes in visual acuity in patients with wet age-related macular degeneration treated with intravitreal ranibizumab in daily clinical practice. Retina. 2013;33(3):474-481. http://dx.doi.org/10.1097/iae.0b013e31827b6324
Souied EH, Oubraham H, Mimoun G, et al. Changes in visual acuity in patients with wet age-related macular degeneration treated with intravitreal ranibizumab in daily clinical practice: the twin study. Retina. 2015;35(9):1743-1749.
Westborg I, Granstam E, Rosso A, Albrecht S, Karlsson N, Lövestam-Adrian M. Treatment for neovascular age-related macular degeneration in Sweden: outcomes at seven years in the Swedish macula register. Acta Ophthalmol. 2017;95(8):787-795.
Jaki Mekjavić P, Gregorčič B, Oberč C, Podgoršek S. Treat-and-extend therapy using intravitreal aflibercept for neovascular age-related macular degeneration: 2-year real-world practice data from Slovenia. BMC Ophthalmol. 2018;18(1):1-7.
Casaroli-Marano R, Gallego-Pinazo R, Fernández-Blanco CT, et al. Age-related macular degeneration: clinical findings following treatment with antiangiogenic drugs. J Ophthalmol. 2014;2014:1-6.
Udaondo P, Salom D, García-Delpech S, Cisneros-Lanuza Á. Aflibercept as first-line therapy in patients with treatment-Naïve Neovascular age-related macular degeneration: prospective case series analysis in real-life clinical practice. Ophthalmologica. 2016;236(1):29-35.
Castro-Navarro V, Cervera-Taulet E, Montero-Hernández J, Navarro-Palop C. One-year outcomes of the treat-and-extend approach with aflibercept in age-related macular degeneration: effects on typical choroidal neovascularization and retinal angiomatous proliferation. Ophthalmologica. 2017;236(4):215-222. http://dx.doi.org/10.1159/000453281
Oca Lázaro AI, Velilla Osés S, Negredo Bravo LJ. Outcomes in patients receiving fixed-dosed aflibercept for treatment-naïve neovascular age-related macular degeneration during one year of routine clinical practice. Arch la Soc Española Oftalmol (English Ed). 2019;94(9):430-435.
Figueras-Roca M, Parrado-Carrillo A, Nguyen V, et al. Treat-and-extend versus fixed bimonthly treatment regimens for treatment-naive neovascular age-related macular degeneration: real world data from the Fight Retinal Blindness registry. Graefes Arch Clin Exp Ophthalmol. 2021;259(6):1463-1470.
Gillies MC, Walton R, Liong J, et al. Efficient capture of high-quality data on outcomes of treatment for macular diseases: the Fight Retinal Blindness! Project. Retina. 2014;34(1):188-195.
Lange C, Feltgen N, Junker B, Schulze-Bonsel K, Bach M. Resolving the clinical acuity categories ‘hand motion’ and ‘counting fingers’ using the Freiburg visual acuity test (FrACT). Graefes Arch Clin Exp Ophthalmol. 2009;247(1):137-142.
Holz FG, Tadayoni R, Beatty S, et al. Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study. Br J Ophthalmol. 2016;100(12):1623-1628.
Holz FG, Tadayoni R, Beatty S, et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015;99(2):220-226.
Ziemssen F, Eter N, Fauser S, et al. Retrospektive Untersuchung der Anti-VEGF-Behandlungsrealität und Wirksamkeit bei Patienten mit neovaskulärer altersabhängiger Makuladegeneration (nAMD) in Deutschland: Behandlungsrealität von Ranibizumab bei nAMD in Deutschland. Ophthalmologe. 2015;112(3):246-254. http://dx.doi.org/10.1007/s00347-014-3217-7
van Asten F, de Jong-Hesse Y, van Lith-Verhoeven JJC, et al. Achieving balance in the treatment and monitoring of neovascular age-related macular degeneration in the real world: lessons from The Netherlands cohort of the AURA study. Acta Ophthalmol. 2019;97(2):e323-e324.
Sivaprasad S, Hykin P, Chakravarthy U, Lotery A, McKibbin M, Napier J. A retrospective study of the real-life utilization and effectiveness of ranibizumab therapy for neovascular age-related macular degeneration in the UK. Clin Ophthalmol. 2016;10:87.
Wykoff CC, Croft DE, Brown DM, et al. Prospective trial of treat-and-extend versus monthly dosing for neovascular age-related macular degeneration: TREX-AMD 1-year results. Ophthalmology. 2015;122(12):2514-2522.
Silva R, Berta A, Larsen M, Macfadden W, Feller C, Monés J. Treat-and-extend versus monthly regimen in neovascular age-related macular degeneration: results with ranibizumab from the TREND study. Ophthalmology. 2018;125(1):57-65.
Kertes PJ, Galic IJ, Greve M, et al. Canadian treat-and-extend analysis trial with ranibizumab in patients with neovascular age-related macular disease: one-year results of the randomized Canadian treat-and-extend analysis trial with ranibizumab study. Ophthalmology. 2019;126(6):841-848.
Ohji M, Takahashi K, Okada AA, Kobayashi M, Matsuda Y, Terano Y. Efficacy and safety of intravitreal aflibercept treat-and-extend regimens in exudative age-related macular degeneration: 52- and 96-week findings from ALTAIR. Adv Ther. 2020;37(3):1173-1187. http://dx.doi.org/10.1007/s12325-020-01236-x
Mitchell P, Holz FG, Hykin P, et al. Efficacy and safety of intravitreal aflibercept using a treat-and-extend regimen for neovascular age-related macular degeneration. Retina. 2021;41(9):1911-1920.
Wykoff CC, Ou WC, Brown DM, et al. Randomized trial of treat-and-extend versus monthly dosing for neovascular age-related macular degeneration. Ophthalmol Retin. 2017;1(4):314-321.
Khanani AM, Skelly A, Bezlyak V, Griner R, Torres LR, Sagkriotis A. SIERRA-AMD: a retrospective, real-world evidence study of patients with neovascular age-related macular degeneration in the United States. Ophthalmol Retin. 2020;4(2):122-133.
Wykoff CC, Clark WL, Nielsen JS, Brill JV, Greene LS, Heggen CL. Optimizing anti-VEGF treatment outcomes for patients with neovascular age-related macular degeneration. J Manag Care Spec Pharm. 2018;24(2-a Suppl2-a):S3-S15. http://dx.doi.org/10.18553/jmcp.2018.24.2-a.s3
Ross AH, Downey L, Devonport H, et al. Recommendations by a UK expert panel on an aflibercept treat-and-extend pathway for the treatment of neovascular age-related macular degeneration. Eye. 2020;34(10):1825-1834.
García-Layana A, García-Arumí J, Figueroa MS, et al. Management of wet age-related macular degeneration in Spain: challenges for treat and extend implementation in routine clinical practice. J Ophthalmol. 2019;2019:1-10.

Auteurs

Javier Zarranz-Ventura (J)

Hospital Clínic de Barcelona, Barcelona, Spain.
Institut de Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.

Alba Parrado-Carrillo (A)

Hospital Clínic de Barcelona, Barcelona, Spain.
Institut de Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.

Vuong Nguyen (V)

Save Sight Institute, Sydney Medical School, University of Sydney, Sydney, Australia.

Laura Sararols (L)

Fundació Privada Hospital Asil Granollers, Granollers, Spain.

Martín Puzo (M)

Hospital Universitario Miguel Servet, Zaragoza, Spain.

Carolina Arruabarrena (C)

Hospital Universitario Principe de Asturias, Madrid, Spain.

Marc Figueras-Roca (M)

Hospital Clínic de Barcelona, Barcelona, Spain.
Institut de Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.

Mark C Gillies (MC)

Save Sight Institute, Sydney Medical School, University of Sydney, Sydney, Australia.

Ricardo P Casaroli-Marano (RP)

Hospital Clínic de Barcelona, Barcelona, Spain.
Institut de Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
Department of Surgery, School of Medicine, Universitat de Barcelona, Barcelona, Spain.
Hospital Clínic de Barcelona, Barcelona, Spain.

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