June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Efficacy and safety of intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) compared with fixed dosing (q8) for neovascular age-related macular degeneration (nAMD): The AZURE study
Author Affiliations & Notes
  • Laurent Kodjikian
    University of Lyon, Lyon, France
    Department of Ophthalmology, Croix-Rousse University Hospital, Lyon, France
  • Lluís Arias Barquet
    Hospital Universitari de Bellvitge, Barcelona, Catalunya, Spain
  • András Papp
    Semmelweis Egyetem, Budapest, Hungary
  • Peter Kertes
    Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
    University of Toronto, Toronto, Ontario, Canada
  • Edoardo Midena
    University Hospital, Padova, Italy
  • Jan Ernest
    Axon Clinical Research Center, Prague, Czechia
  • Rufino Silva
    University of Coimbra, Coimbra Institute for Clinical and Biomedical Research (iCBR), Coimbra, Portugal
    Faculty of Medicine, Coimbra, Portugal
  • Thomas Schmelter
    Bayer AG, Leverkusen, Nordrhein-Westfalen, Germany
  • Tobias Niesen
    Bayer AG, Berlin, Germany
  • Sergio Leal
    Bayer Consumer Care AG, Basel, Basel-Stadt, Switzerland
  • Footnotes
    Commercial Relationships   Laurent Kodjikian, AbbVie/Allergan (C), Alimera/Horus (C), Bayer (C), Novartis (C), Roche (C), Thea (C); Lluís Arias Barquet, Allergan (C), Bayer (C), Novartis (C), Roche (C), Topcon (C); András Papp, Allergan (F), Amgen (F), Bayer (F), Bayer (C), Bioeq (F), Chengdu Kanghong (F), Clearside Biomedical (F), Genentech (F), Novartis (F), Novartis (C), Oculis (F), Ophthtotec/Iveric Bio (F), Panoptica (F), Qilu (F), Regeneron (F), Roche (F), Roche (C), Samsung Bioepis (F), Thrombogenics (F), Xbrain (F); Peter Kertes, Alcon (S), Allergan (F), Allergan (S), ArcticDx (I), Bayer (F), Bayer (S), Novartis (F), Novartis (S), Novelty Nobility (S), Roche (F), Roche (S), Zeiss (F); Edoardo Midena, Bayer (S); Jan Ernest, None; Rufino Silva, Alimera (C), Allergan (C), Bayer (C), Novartis (C), Novo Nordisk (C), Roche (C), Thea (C); Thomas Schmelter, Bayer (I); Tobias Niesen, Bayer (I); Sergio Leal, Bayer (I)
  • Footnotes
    Support  This study was funded by Bayer Consumer Care AG. Medical writing and editorial assistance was provided by ApotheCom and was funded by Bayer Consumer Care AG
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 425. doi:
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      Laurent Kodjikian, Lluís Arias Barquet, András Papp, Peter Kertes, Edoardo Midena, Jan Ernest, Rufino Silva, Thomas Schmelter, Tobias Niesen, Sergio Leal; Efficacy and safety of intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) compared with fixed dosing (q8) for neovascular age-related macular degeneration (nAMD): The AZURE study. Invest. Ophthalmol. Vis. Sci. 2021;62(8):425.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : To compare the efficacy and safety of 2 IVT-AFL dosing regimens, T&E and q8, for patients with nAMD beyond Year (Y) 1 of treatment.

Methods : AZURE (NCT02540954) was a randomized, multicenter study. All patients completed ≥1Y of IVT-AFL treatment prior to enrollment. Patients were randomized 1:1 to fixed q8 (2mg IVT-AFL every 8 weeks [w]) or T&E dosing (IVT-AFL ≥8w [no upper limit] per functional/anatomic criteria). Primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline (BL) to w52. Key secondary endpoint was proportion of patients losing <15 letters.

Results : The full analysis set comprised 332 patients (n=167 [q8] and n=165 [T&E]). Mean (standard deviation) BCVA at IVT-AFL treatment initiation (1Y prior to study BL) was 60.9 (9.9; q8) and 59.4 (10.5; T&E) letters. At study BL, mean age was 74.7 (7.0; q8) and 76.2 (8.3; T&E) and mean BCVA was 70.1 (10.9; q8) and 69.0 (12.1; T&E) letters. At w52, mean BCVA change from BL was −0.5 (8.4; q8) and −0.3 (7.5; T&E) letters. Least-squares mean difference (95% CI) vs q8 dosing was 0.22 (−1.51; 1.96). Compared with q8 dosing, T&E achieved a non-inferior change in mean BCVA at w52 (pre-specified margin of 5 letters; P<0.0001). At w76, mean BCVA change from BL was −0.9 (10.4; q8) and −1.5 (10.9; T&E) letters. From BL to w52, 94.0% (q8) and 95.2% (T&E) of patients maintained vision (<15-letter loss). Mean central retinal thickness change from BL was −33.4µm (47.1; q8) and −24.4µm (55.2; T&E) at w52, and −37.8µm (51.1; q8) and −21.7µm (57.0; T&E) at w76. Mean number of IVT-AFL injections was 6.8 (0.8; q8) and 6.0 (1.0; T&E) at w52, and 9.6 (1.4; q8) and 8.0 (1.8; T&E) at w76. Ocular treatment-emergent adverse events in the study eye were similar for q8 (48.8%) and T&E (45.5%) dosing regimens.

Conclusions : In patients who previously received ≥1Y of IVT-AFL treatment for nAMD, T&E dosing achieved similar functional outcomes as q8 dosing. Functional and anatomic improvements achieved during Y1 were maintained in Y2 and Y3 of IVT-AFL treatment with both regimens. Of the 2 regimens, T&E required fewer injections. No new safety signals were identified, which is consistent with prior studies.

This is a 2021 ARVO Annual Meeting abstract.


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