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Visual benefit versus visual gain: what is the effect of baseline covariants in the treatment arm relative to the control arm? A pooled analysis of ANCHOR and MARINA
  1. Adnan Tufail1,
  2. Philippe Margaron2,
  3. Tadhg Guerin3,
  4. Michael Larsen4
  1. 1 Medical Retina, Moorfields Eye Hospital & Institute of Ophthalmology UCL, London, UK
  2. 2 Novartis Pharma, Basel, Switzerland
  3. 3 Theravance Biopharma, Dublin, Ireland
  4. 4 Department of Ophthalmology, Rigshospitalet & Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  1. Correspondence to Dr Adnan Tufail, Moorfields Eye Hospital, London, EC1V 2PD, UK; adnan.tufail{at}moorfields.nhs.uk

Abstract

Background This study aimed to elucidate visual benefits of ranibizumab in patients with neovascular age-related macular degeneration (nAMD) compared with control arms and identify factors affecting response.

Methods This is a post-hoc pooled analysis of two phase III studies, ANCHOR and MARINA, of ranibizumab for the treatment of nAMD. ANCHOR included 83 international sites. MARINA included 96 sites in the USA. Analysis included patients (control, n=323; ranibizumab, n=332) with nAMD and a baseline best-corrected visual acuity (BCVA) of ≥35–<85 letters.

Results Patients receiving ranibizumab achieved an adjusted mean BCVA superiority of 18.9 and 21.2 letters over 12 and 24 months, respectively, compared with control. Ranibizumab treatment, higher baseline BCVA, lower age and smaller lesion size were positively associated with the ability to achieve BCVA >69 letters. Patients with the highest baseline BCVA had lowest BCVA gains. Ranibizumab treatment, lower baseline BCVA, lower age and smaller lesion size were identified as significant predictors of BCVA gain from baseline at month 24 (all p<0.0001). However, the difference in mean BCVA gains at month 24 between treatment and control groups was similar for all baseline BCVA subgroups (≥35–<55 letters, 21.9 letters; ≥55–<70 letters, 25.2 letters; ≥70–<85 letters, 19.3 letters).

Conclusions Higher baseline BCVA is associated with lower BCVA gains but a greater likelihood of achieving good final BCVA >69 letters due to smaller gains needed to achieve response. Visual benefits, including maintenance of visual acuity (VA), final VA achieved and relative gain compared with natural disease progression, should be considered when assessing treatment response in nAMD.

  • retina
  • vision

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Footnotes

  • Contributors AT, PM, TG and ML were involved in the interpretation of the data, preparation, review and approval of the manuscript, as well as in the decision to submit the manuscript for publication. TG had full access to all of the data in the study and takes responsibility for the integrity and accuracy of the data analysis.

  • Funding Dr Tufail has received a proportion of his funding from the Department of Health’s NIHR Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital and UCL Institute of Ophthalmology. The views expressed in the publication are those of the author and not necessarily those of the Department of Health.

  • Competing interests AT: consultant for Allergan, Bayer, Genentech, Heidelberg Engineering, Novartis, Roche and received grant support from Novartis. ML: received lecture fees and the Rigshospitalet center has received compensation for the conduct of clinical trials from Allergan, Alcon, Novartis; Novo Nordisk, AbbVie and Roche. TG: employee of Novartis Ireland Limited, Dublin, Ireland during manuscript development and currently employed with Theravance Biopharma US, South San Francisco, CA. PM: employee of Novartis Pharma AG, Basel, Switzerland.

  • Patient consent for publication Not required.

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

  • Data availability statement Data are available on request.

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