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Clinical science
Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study
  1. Frank G Holz1,
  2. Ramin Tadayoni2,
  3. Stephen Beatty3,
  4. Alan Berger4,
  5. Matteo Giuseppe Cereda5,
  6. Philip Hykin6,
  7. Giovanni Staurenghi5,
  8. Kim Wittrup-Jensen7,
  9. Andreas Altemark7,
  10. Jonas Nilsson8,
  11. Kun Kim8,
  12. Sobha Sivaprasad6,9
  1. 1Department of Ophthalmology, University of Bonn, Bonn, Germany
  2. 2Department of Ophthalmology, Hôpital Lariboisière, AP-HP, Université Paris 7—Sorbonne Paris Cité, Paris, France
  3. 3Department of Ophthalmology, Institute of Eye Surgery, Waterford, Ireland
  4. 4Department of Ophthalmology and Vision Sciences, University of Toronto, and St Michael's Hospital, Toronto, Ontario, Canada
  5. 5Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy
  6. 6NIHR Biomedical Centre for Research in Ophthalmology, Moorfields Eye Hospital, London, UK
  7. 7Bayer Pharma AG, Berlin, Germany
  8. 8Mapi Group, Real World Strategy and Analytics, Stockholm, Sweden
  9. 9Department of Ophthalmology, King's College Hospital, London, UK
  1. Correspondence to Sobha Sivaprasad, King's College Hospital, Denmark Hill, London SE5 9RS, UK; senswathi{at}aol.com

Abstract

Background/aims To identify predictive markers for the outcomes of anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration (nAMD).

Methods AURA was a retrospective, observational, multicentre study that monitored the 2-year outcomes following intravitreal ranibizumab treatment in patients with nAMD. Using stepwise regression analysis, we evaluated the association between visual acuity outcomes, baseline characteristics and resource utilisation in order to determine which variables are significantly linked to outcomes in AURA. We also examined the relationship between visual acuity outcomes and number of injections received.

Results Analyses were performed using data from year 1 (n=1695) and year 2 completers (n=1184). Logistic analysis showed that baseline visual acuity score, age at start of therapy, number of ophthalmoscopies and optical coherence tomography (OCT) (combined) and number of injections (ranibizumab) were significant (p<0.05) prognostic factors for vision maintenance (loss <15 letters) or vision gain (≥15 letters). Patients who received >7 injections (in 1 year) or >14 injections (over 2 years) gained more letters and demonstrated greater vision maintenance (loss of <15 letters) than patients who received fewer injections. There was a significant (p<0.05) association between number of injections and national reimbursement schemes and OCT.

Conclusions A number of factors that are predictive of treatment outcomes in a real-life setting were identified. Notably, the decline of treatment benefits may be linked to number of injections and a failure to visit clinicians and receive OCT as required. These findings may be helpful in guiding ophthalmologist treatment decisions under limited time and financial constraints.

Trial registration number NCT01447043.

  • Drugs
  • Macula
  • Retina
  • Treatment Medical
  • Vision

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bjophthalmol-2015-308166

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    Footnotes

    • Contributors FGH, RT, SB, AB, MGC, PH, GS and SS are members of the Global Steering/Publication Committee for the AURA study and were involved in provision of patient/data acquisition, data analysis, data review and interpretation. AA was involved in the design of the AURA study and protocol, and participated in discussions on the interpretation of the data. KW-J, JN and KK were involved in the design, data collection, analysis and interpretation of the regression analyses of AURA. All authors provided critical review of the manuscript and approved the final version for publication.

    • Funding The study was funded by Bayer HealthCare Pharmaceuticals. The sponsor or funding organisation participated in the design and conduct of the study, data collection, data management, data analysis, interpretation of the data and preparation of manuscript.

    • Competing interests FGH is a consultant to Acucela, Genentech, Novartis, Bayer HealthCare, Alcon, OPTOS, Heidelberg Engineering, Carl Zeiss Meditec, Allergan and Pfizer, and has received grants from OPTOS, Heidelberg Engineering, Carl Zeiss Meditec, Alcon, Genentech, Bayer HealthCare and Novartis. RT is a board member of Alcon, Novartis, Allergan, Bausch & Lomb, Pfizer, Alimera, Bayer HealthCare and FCI-Zeiss, and a consultant for Allergan, DORC, Alcon, Novartis, Takeda, Bausch & Lomb and FCI-Zeiss. He has received payment for lectures from Alcon, Bausch & Lomb, Novartis, Allergan, Pfizer, Takeda, Bayer HealthCare and Alimera, and has received payment for development of educational presentations from Bausch & Lomb, Novartis, Zeiss, Sony, Alcon and Allergan. He has also received support for meeting expenses (travel and accommodation) from Alcon, Novartis, Allergan, Bausch & Lomb, Pfizer, Bayer HealthCare, DORC, Takeda, Servier and Alimera. SB is a consultant and board member for Bayer HealthCare, and has received support for travel to meetings and fees for participation in review activities from Bayer HealthCare. AB has received honoraria from Bayer HealthCare, Novartis, Alcon and Allergan. Institutional research funding support was received from Bayer HealthCare, Novartis and Alcon. Fellowship support funding was received from Alcon, Bayer HealthCare, Novartis and Woodgreen Pharmacy. He has received travel fees and speaker fees and participated in advisory boards for Bayer HealthCare and Novartis. MGC is a consultant to Bayer HealthCare and has received support for travel to meetings from Bayer HealthCare and Alcon. PH has received grants from Bayer HealthCare, Allergan and Novartis, and acts as a consultant to Bayer HealthCare, Novartis and Allergan. He has also received support for travel to meetings, for participation in review activities and provision of writing assistance, medicines, equipment or administrative support from Bayer HealthCare, has received payment for lectures from Allergan and Novartis and has received support for conference attendance. GS acts as a consultant to Novartis, Bayer HealthCare, Allergan, Genentech, Roche, Heidelberg Engineering and Alcon. He has also received support for travel to meetings from Bayer HealthCare, Centervue, Heidelberg Engineering and Novartis. He has received payment for lectures from Zeiss, and is a patent holder in conjunction with Ocular Instruments, Inc. He has received payment for development of educational presentations for Roche. SS has received research grants from Bayer HealthCare, Novartis and Allergan that were paid to her institution. She has received travel fees and speaker fees and has participated in advisory boards for Bayer HealthCare, Novartis and Allergan, and has participated in an advisory board meeting for Roche. AA and KW-J are employees of Bayer HealthCare. JN and KK are employees of Mapi Group, who were contracted by Bayer HealthCare to perform the analyses.

    • Patient consent Obtained.

    • Ethics approval Country IEC and IRB.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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