June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Comparison of treat-and-extend (T&E) dosing regimens and visual outcomes in the ARIES and ALTAIR studies of intravitreal aflibercept (IVT-AFL) in neovascular age-related macular degeneration (nAMD)
Author Affiliations & Notes
  • Paul Mitchell
    Ophthalmology, University of Sydney (Westmead Institute for Medical Research), North Sydney, New South Wales, Australia
  • Frank G. Holz
    Department of Ophthalmology, University of Bonn, Bonn, Germany
  • Philip G Hykin
    Ophthalmology, Moorfields Eye Hospital, London, United Kingdom
  • Edoardo Midena
    Department of Ophthalmology, University of Padova, Padova, Italy
  • Annabelle A Okada
    Department of Ophthalmology, Kyorin University, School of Medicine, Tokyo, Japan
  • Eric H Souied
    Department d’Ophthalmolgie, Hopital Intercommunal de Creteil, Creteil, France
  • Kanji Takahashi
    Department of Ophthalmology, Kansai Medical University, Osaka, Japan
  • Sebastian Wolf
    Department of Ophthalmology, Inselspital, University of Bern, Bern, Switzerland
  • Helmut Allmeier
    Bayer Consumer Care AG, Basel, Switzerland
  • George Lambrou
    Bayer Consumer Care AG, Basel, Switzerland
  • Thomas Schmelter
    Bayer Consumer Care AG, Berlin, Germany
  • Masahito Ohji
    Department of Ophthalmology, Shiga University of Medical Science, Otsu, Japan
  • Footnotes
    Commercial Relationships   Paul Mitchell, Allergan (C), Bayer (C), Novartis (C); Frank G. Holz, Acucela (C), Allergan (R), Apellis (C), Bayer (C), Bioeq/Formycon (F), Boehringer-Ingelheim (C), CenterVue (F), Ellex (R), Geuder (C), Grayburg Vision (C), Heidelberg Engineering (C), Kanghong (C), Kodiak (C), LinBioscience (C), NightStarX (F), Novartis (C), Optos (F), Oxurion (C), Pixium Vision (C), Roche/Genentech (C), Stealth BioTherapeutics (C), Zeiss (F); Philip Hykin, Allergan (C), Allergan (R), Bayer (F), Bayer (R), Bayer Healthcare (C), Novartis (C), Novartis (R); Edoardo Midena, None; Annabelle Okada, AbbVie Japan, Inc. (R), Alcon Pharma K.K. (Japan) (F), Alcon Pharma K.K. (Japan) (R), Astellas Japan (R), Bayer Healthcare AG (R), Bayer Yakuhin Ltd. (Japan) (F), Bayer Yakuhin Ltd. (Japan) (R), Daiichi-Sankyo (R), Mitsubishi Tanabe Pharma Corporation (F), Mitsubishi Tanabe Pharma Corporation (R), Santen Pharmaceuticals Co., Ltd. (Japan) (F), Santen Pharmaceuticals Co., Ltd. (Japan) (R), Senju Pharmaceutical Co., Ltd (R); Eric Souied, None; Kanji Takahashi, Alcon Pharma K.K. (Japan) (C), Alcon Pharma K.K. (Japan) (R), B.L.J Ltd. (C), B.L.J Ltd. (R), Bayer Yakuhin, Ltd. (Japan) (C), Bayer Yakuhin, Ltd. (Japan) (R), Carl Zeiss Co., Ltd. (R), Carl Zeiss Co., Ltd. (C), Kowa (C), Kowa (R), Kyowa Kirin Co., Ltd (C), Kyowa Kirin Co., Ltd. (R), Novartis Pharma K.K. (C), Novartis Pharma K.K. (R), Otsuka Pharmaceuticals (C), Otsuka Pharmaceuticals (R), Pfizer Pharmaceuticals K.K. (C), Pfizer Pharmaceuticals K.K. (R), Santen Pharmaceuticals Co., Ltd. (R), Santen Pharmaceuticals Co., Ltd. (C), Senju Pharmaceutical Co., Ltd (R); Sebastian Wolf, Allergan (C), Bayer (C), Heidelberg Engineering (F), Heidelberg Engineering (C), Novartis (C), Optos (C), Roche (C), Zeiss (C); Helmut Allmeier, Bayer Consumer Care AG (E); George Lambrou, Bayer Consumer Care AG (E); Thomas Schmelter, Bayer Consumer Care AG (E); Masahito Ohji, AbbVie Japan, Inc. (F), AbbVie Japan, Inc. (C), Alcon Pharma K.K. (Japan) (C), Alcon Pharma K.K. (Japan) (R), Alcon Pharma K.K. (Japan) (F), Allergan, B.L.J Ltd. (C), Allergan, B.L.J Ltd. (R), Allergan, B.L.J Ltd. (F), Bayer Yakuhin, Ltd. (Japan) (C), Bayer Yakuhin, Ltd. (Japan) (R), Bayer Yakuhin, Ltd. (Japan) (F), Chugai (F,C,R), (F), Chugai (F,C,R), (C), Chugai (F,C,R), (R), HOYA (F), HOYA (C), HOYA (R), Kowa (F), Novartis Pharma K.K. (C), Otsuka Pharmaceuticals (F), Pfizer Pharmaceuticals K.K (F), Santen Pharmaceuticals Co., Ltd. (C), Senju Pharmaceutical Co., Ltd. (F), Topcon (F)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2020, Vol.61, 4219. doi:
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      Paul Mitchell, Frank G. Holz, Philip G Hykin, Edoardo Midena, Annabelle A Okada, Eric H Souied, Kanji Takahashi, Sebastian Wolf, Helmut Allmeier, George Lambrou, Thomas Schmelter, Masahito Ohji; Comparison of treat-and-extend (T&E) dosing regimens and visual outcomes in the ARIES and ALTAIR studies of intravitreal aflibercept (IVT-AFL) in neovascular age-related macular degeneration (nAMD). Invest. Ophthalmol. Vis. Sci. 2020;61(7):4219.

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

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Abstract

Purpose : To compare the criteria used for adjusting T&E treatment intervals and visual outcomes in two large multicenter, randomized Phase 4 studies (ARIES and ALTAIR) evaluating the efficacy and safety of IVT-AFL in nAMD using T&E dosing regimens.

Methods : In ARIES (NCT02581891; 104 weeks) and ALTAIR (NCT02305238; 96 weeks), patients received 3 initial monthly doses of 2mg IVT-AFL (Weeks [W] 0, 4, and 8), followed by an injection at W16. In ARIES, patients were randomized at W16 to an early-start T&E arm (T&E extended in 2-week steps) or a late-start T&E arm (2mg IVT-AFL every 8 weeks until W52, followed by T&E in 2-week steps). In ALTAIR, patients were randomized at W16 to T&E groups with either a 2 or 4-week injection interval adjustment. The T&E treatment interval adjustment criteria differed between the studies. ARIES criteria for interval adjustment were: no intraretinal fluid AND no new neovascularization or hemorrhage AND subretinal thickness <50μm. ALTAIR criteria for interval extension were: no fluid AND ≤5 Early Treatment Diabetic Retinopathy Study (ETDRS) letter loss AND central retinal thickness increase ≤100µm AND no new neovascularization or hemorrhage. Additionally, ALTAIR introduced criteria to allow maintenance of treatment intervals.

Results : Combined average outcomes of the two treatment arms in each study (early/late-start in ARIES and 2 vs 4-week intervals in ALTAIR) were similar: in ARIES/ALTAIR mean best-corrected visual acuity (ETDRS letters) was 60.7/55.0 at baseline; 68.1/64.0 at randomization (W16); 69.7/63.7 at Year 1 (W52); and 66.8/61.9 at Year 2 (W104/W96), respectively. A mean last injection interval of ≥12 and ≥16 weeks was achieved in 49.5%/58.5% and 28.6%/43.9% of patients in ARIES/ALTAIR, respectively. The mean number of injections in ARIES/ALTAIR at W52, respectively, was 7.5/7.0 and at study end was 12.5 (ARIES, W104) and 10.4 (ALTAIR, W96).

Conclusions : ARIES and ALTAIR demonstrated that treatment intervals of ≥12 weeks and good improvement of visual outcomes (>5-letter gain) can be achieved with IVT-AFL T&E dosing in patients with nAMD. Fine-tuning of the T&E regimen by means of an interval-maintenance step and of functional criteria, as introduced by ALTAIR, could potentially further reduce patient burden by increasing treatment intervals.

This is a 2020 ARVO Annual Meeting abstract.

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