June 2020
Volume 61, Issue 7
ARVO Annual Meeting Abstract  |   June 2020
Efficacy of Intravitreal Aflibercept Treat-and-Extend Regimen Over 2 Years for Neovascular Age-Related Macular Degeneration: ARIES Study
Author Affiliations & Notes
  • Eric H Souied
    Department d’Ophthalmolgie, Hopital Intercommunal de Creteil, Creteil, France
  • Frank G. Holz
    Department of Ophthalmology, University of Bonn, Bonn, Germany
  • Philip G Hykin
    Moorfields Eye Hospital, London, United Kingdom
  • Edoardo Midena
    University of Padova, Padova, Italy
  • Sebastian Wolf
    Reading Centre and department for Ophthalmology, Switzerland
  • Helmut Allmeier
    Bayer Consumer Care, AG, Basel, Switzerland
  • Paul Mitchell
    University of Sydney (Westmead Institute for Medical Research), Sydney, New South Wales, Australia
  • Footnotes
    Commercial Relationships   Eric Souied, None; Frank G. Holz, Acucela (C), Allergan (F), Apellis (C), Bayer (C), Bioeq/Formycon (F), Boehringer Ingleheim (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; Sebastian Wolf, Allergan (C), Bayer (C), Heidelberg Engineering (F), Heidelberg Engineering (C), Novartis (C), Optos Inc (C), Roche (C), Zeiss (C); Helmut Allmeier, Bayer (E); Paul Mitchell, Allergan (C), Bayer (C), Novartis (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 4210. doi:
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      Eric H Souied, Frank G. Holz, Philip G Hykin, Edoardo Midena, Sebastian Wolf, Helmut Allmeier, Paul Mitchell; Efficacy of Intravitreal Aflibercept Treat-and-Extend Regimen Over 2 Years for Neovascular Age-Related Macular Degeneration: ARIES Study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4210.

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

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Purpose : To assess whether intravitreal aflibercept (IVT-AFL) injection administered in an early treat-and-extend (T&E) regimen was non-inferior to a late-start T&E regimen in patients with treatment-naïve neovascular age-related macular degeneration (nAMD).

Methods : ARIES (NCT02581891) was a multicenter, randomized, open-label, Phase 3b/4 study. All patients received 3 initial monthly doses of 2mg IVT-AFL (Weeks 0, 4, and 8). At Week 16, patients received IVT-AFL and were randomized 1:1 to an early-start T&E arm (IVT-AFL T&E regimen extended by 2 weeks or an initial 4-week interval [maximum 16 weeks]) or a late-start T&E arm (IVT-AFL every 8 weeks until Week 52, followed by a T&E regimen). Primary endpoint was change in best-corrected visual acuity (BCVA, ETDRS letters) from randomization (Week 16) to Week 104. To identify predictors of extension, treatment behavior was clustered according to injection interval pattern using tree-based modeling methods.

Results : 271 patients were randomized. At Week 104, mean BCVA change from Week 16 was –2.1 vs –0.4 ETDRS letters, and from baseline was +4.3 vs +7.9 ETDRS letters (early- vs late-start arms). Mean number of injections was 12.0 vs 13.0 (early- vs late-start arms). Around half of the letter-score difference between the groups was already evident at Week 16. From baseline to Week 104, 93.4% and 96.2% (early- and late-start arms) maintained BCVA (<15 ETDRS letter loss), which is similar or better than observed in pivotal trials. Mean change in central retinal thickness was −162µm and −159µm (early- and late-start arms; baseline to Week 104). Last injection interval at Week 104 was ≥12 weeks for 47.2% and 51.9% of patients (early- and late-start arms). No strong predictors for clusters with longer injection interval patterns were found, but central subfield thickness (CST) at Week 16 showed the highest association, while baseline variables such as CST or BCVA were weaker. The safety profile was consistent with previous studies.

Conclusions : These results demonstrate a relative consistency of outcomes with both early- and late-start IVT-AFL T&E regimens for the treatment of nAMD. The observed mean reduction in the number of injections with early-start T&E following initial dosing was clinically relevant

This is a 2020 ARVO Annual Meeting abstract.


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