June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E): post-hoc analysis of injection intensive (I-I) requirement for patients in the ARIES study
Author Affiliations & Notes
  • Sebastian Wolf
    Reading Centre and Department for Ophthalmology, Inselspital, University of Bern, Switzerland
  • Frank G Holz
    Department of Ophthalmology, University of Bonn, Germany
  • Philip Hykin
    Ophthalmology, Moorfields Eye Hospital, United Kingdom
  • Edoardo Midena
    Department of Ophthalmology, University of Padova, Italy
  • Eric H Souied
    Department d’Ophthalmolgie, Hopital Intercommunal de Creteil, France
  • George Lambrou
    Bayer Consumer Care AG, Basel, Switzerland
  • Tobias Machewitz
    Bayer AG, Berlin, Germany
  • Helmut Allmeier
    Bayer Consumer Care AG, Basel, Switzerland
  • Paul Mitchell
    University of Sydney, New South Wales, Australia
  • Footnotes
    Commercial Relationships   Sebastian Wolf, Allergan (C), Bayer (C), Bayer (S), Boehringer-Ingelheim (C), Chengdu Kanghong Biotech (C), Heidelberg Engineering (F), Heidelberg Engineering (C), Novartis (C), Oxurion (C), Roche (C), Zeiss (C); Frank Holz, Acucela (F), Acucela (C), Apellis Pharmaceuticals (F), Apellis Pharmaceuticals (C), Bayer (F), Bayer (C), Bioeq/Formycon AG (F), Bioeq/Formycon AG (C), Boehringer-Ingelheim (C), CenterVue (F), Chengdu Kanghong Pharmaceuticals (F), Chengdu Kanghong Pharmaceuticals (C), Geuder AG (C), Graybug Vision (C), Heidelberg Engineering (F), Heidelberg Engineering (C), Lin Bioscience (C), NightstaRx (F), Novartis (F), Novartis (C), Optos (F), Pixium Vision (F), Roche/Genentech (F), Roche/Genentech (C), Zeiss Pharma (F); Philip Hykin, Allergan (C), Allergan (R), Bayer (S), Bayer HealthCare (C), Bayer HealthCare (R), Novartis (C), Novartis (R); Edoardo Midena, Bayer (S); Eric Souied, Bayer (S); George Lambrou, Bayer (E); Tobias Machewitz, Bayer (E); Helmut Allmeier, Bayer (E); Paul Mitchell, Allergan (C), Bayer (C), Bayer (S), Novartis (C)
  • 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, 423. doi:
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      Sebastian Wolf, Frank G Holz, Philip Hykin, Edoardo Midena, Eric H Souied, George Lambrou, Tobias Machewitz, Helmut Allmeier, Paul Mitchell; Neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E): post-hoc analysis of injection intensive (I-I) requirement for patients in the ARIES study. Invest. Ophthalmol. Vis. Sci. 2021;62(8):423.

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

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Abstract

Purpose : To assess vision and anatomic outcomes in patients with nAMD and the requirement for IVT-AFL treatment more frequently than every 8 weeks (w).

Methods : ARIES (NCT02581891) was a multicenter, randomized, Phase 3b/4 study that compared the efficacy of 2 IVT-AFL T&E regimens over 2 years (Y) in treatment-naïve nAMD patients. Patients were determined as I-I if the study investigator identified need for treatment more frequently than every 8w and if patients had ≥1 treatment interval of 4 or 6w after 3 initial monthly doses. This was a post-hoc analysis of patients enrolled in ARIES and statistical analysis is descriptive.

Results : The full analysis set comprised 269 patients (treatment arms combined). Overall, 23.0% (n=62) of patients were determined as I-I; 13.8% (n=37) in Y1 and 9.3% (n=25) in Y2. There were no relevant differences in baseline characteristics between I-I and non-I-I patients. Time from IVT-AFL initiation to the visit where patients were determined I-I varied considerably (range: 16–100w; median: 43.2w). Mean treatment interval was 8.4w before patients were determined as I-I and 6.1w following I-I determination. Mean (SD) best-corrected visual acuity (BCVA) was lower and central retinal thickness (CRT) was higher in I-I patients at the visit when they were determined I-I compared with w16 (BCVA: 61.9 [16.7] vs 65.7 [12.6] letters; CRT: 410.7 [112.3] vs 379.0 [112.6] µm). With treatment more frequent than every 8w, these patients showed BCVA (62.6 [18.7] letters) and CRT (336.8 [101.0] µm) improvements at w104. Improvements in vision from baseline (BL) to w104 were smaller for I-I patients than non-I-I patients (+2.3 [15.6] vs +5.9 [12.3] letters). Anatomic outcomes at w104 were similar between I-I and non-I-I patients (CRT change from BL: −160.4 [154.0] µm and −167.0 [136.1] µm). Overall, 59.7% of patients achieved treatment intervals of ≥8w following I-I determination.

Conclusions : The need for IVT-AFL treatment more frequently than every 8w may arise at various points over the course of nAMD treatment. Up to 1 in 4 patients may require more intensive treatment than every 8w. These patients showed improvements in vision and anatomic outcomes. For most, treatment intervals could be extended to ≥8w following I-I determination.

This is a 2021 ARVO Annual Meeting abstract.

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