July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Efficacy of Intravitreal Aflibercept Administered using Treat-and-Extend Regimen over 2 Years in Patients with Neovascular Age-Related Macular Degeneration: 1-Year ARIES Results.
Author Affiliations & Notes
  • Paul Mitchell
    Ophthalmology, University of Sydney, North Sydney, New South Wales, Australia
  • Eric H Souied
    Hopital Intercommunal de Creteil, Department d’ophthalmolgie, Creteil, France
  • Edoardo Midena
    University of Padova, Department of Ophthalmology, Padova, Italy
  • Frank G Holz
    Department of Ophthalmology, University of Bonn, Bonn, Germany
  • Philip G Hykin
    Moorfields Eye Hospital, Ophthalmology, London, United Kingdom
  • Sebastian Wolf
    Reading Centre and department for Ophthalmology, Inselspital, Bern, Switzerland
  • Helmut Allmeier
    Bayer AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Paul Mitchell, Abbott (F), Allergan (F), Bayer (F), Novartis (F), Roche (F); Eric Souied, Allergan (F), Allergan (C), Bayer (F), Bayer (C), Novartis (F), Novartis (C), Roche (F), Roche (C), Thea Pharmaceuticals (F), Thea Pharmaceuticals (C); Edoardo Midena, None; Frank Holz, Acucela (C), Allergan (C), Bayer (C), Genentech/Roche (C), GSK (C), Heidelberg Engineering (C), Merck (C), Novartis (C), Thrombogenics (C); Philip Hykin, Allergan (F), Allergan (C), Bayer (F), Bayer (C), Novartis (F), Novartis (C); Sebastian Wolf, Acucela (F), Alcon (F), Allergan (F), Bayer Healthcare (F), Boehringer Ingelheim (F), Carl Zeiss Meditec (F), Genentech (F), GlaxoSmithKline (F), Heidelberg Engineering (F), Merz (F), Novartis (F), Optos (F), Pfizer (F); Helmut Allmeier, Bayer (E)
  • Footnotes
    Support  Bayer HealthCare SAS
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 117. doi:https://doi.org/
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      Paul Mitchell, Eric H Souied, Edoardo Midena, Frank G Holz, Philip G Hykin, Sebastian Wolf, Helmut Allmeier; Efficacy of Intravitreal Aflibercept Administered using Treat-and-Extend Regimen over 2 Years in Patients with Neovascular Age-Related Macular Degeneration: 1-Year ARIES Results.. Invest. Ophthalmol. Vis. Sci. 2019;60(9):117. doi: https://doi.org/.

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

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Abstract

Purpose : To assess whether intravitreal aflibercept injection (IAI) administered in an early treat-and-extend (T&E) regimen is noninferior to a late-start T&E regimen in neovascular age-related macular degeneration (nAMD).

Methods : ARIES (NCT02581891) is a multicentre, randomised, open-label, active-controlled, parallel-group, Phase 3b/4 study comparing the efficacy of IAI administered by 2 different T&E regimens over 2 years in treatment-naïve patients with nAMD. All patients received 3 initial monthly doses of IAI (Weeks 0, 4, and 8), followed by an injection at an 8-week treatment interval (Week 16). At Week 16, patients were randomised 1:1 to an early-start T&E arm (T&E regimen extended by 2 weeks or an initial 4-week interval [maximum 16 weeks]) or a late-start T&E arm (2 mg IAI every 8 weeks [2q8] until Week 52, followed by T&E). Primary endpoint is change in best-corrected visual acuity (BCVA) from randomisation (Week 16) to Week 104. Interim results at Week 52 are presented here.

Results : A total of 287 treatment-naïve patients with nAMD were enrolled. At Week 16, 271 patients were randomised to an early-start T&E or fixed 2q8 regimen. Baseline characteristics were largely similar between treatment arms. At Week 52, absolute BCVA letter score change (67.6 vs 68.3 ETDRS letters), from randomisation (+0.9 vs +1.1 ETDRS letter difference), and mean number of injections (7.2 vs 8.0) were similar in patients in the early-start T&E and fixed 2q8 regimen treatment arms, respectively. The proportion maintaining visual acuity at Week 52 was 98.5% and 97.8% in early-start T&E and fixed 2q8 regimens, respectively, similar or better than observed in pivotal trials. By Week 52, mean central retinal thickness was decreased by 160 and 178 µm on average from baseline in early-start T&E and fixed 2q8 regimens, respectively. The proportion with study eye ocular serious adverse events was 0.0% (early-start T&E) and 2.2% (fixed 2q8 regimen). This safety profile is consistent with previous studies.

Conclusions : Interim 52-week results from ARIES support outcomes with a T&E IAI regimen after the first 8-week interval and are consistent with a 2q8 fixed treatment approach over the first year in treating nAMD. The observed average reduction in injection number after loading is clinically relevant.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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