Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
Authors Dugel P, Hillenkamp J, Sivaprasad S, Vögeler J, Mousseau M, Wenzel A, Margaron P, Hashmonay R, Massin P
Received 18 November 2015
Accepted for publication 18 February 2016
Published 14 June 2016 Volume 2016:10 Pages 1103—1110
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Pravin U Dugel,1,2 Jost Hillenkamp,3 Sobha Sivaprasad,4,5 Jessica Vögeler,6 Marie-Catherine Mousseau,7 Andreas Wenzel,8 Philippe Margaron,8 Ron Hashmonay,8 Pascale Massin9
1Retinal Consultants of Arizona LTD, Retinal Research Institute LLC, Phoenix, AZ, 2USC Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 3Department of Ophthalmology, Julius-Maximilians University, Würzburg, Germany; 4NIHR Biomedical Research Centre, Moorfields Eye Hospital, London, 5King’s College Hospital, London, UK; 6Novartis Pharma GmbH, Nürnberg, Germany; 7Novartis Ireland Limited, Dublin, Ireland; 8Novartis Pharma AG, Basel, Switzerland; 9Department of Ophthalmology, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, Université Paris Diderot, Paris, France
Objective: This study was designed to evaluate the correlation of baseline visual acuity (VA) with VA outcome in response to anti-vascular endothelial growth factor (VEGF) in diabetic macular edema using a retrospective analysis of nine clinical trials. The result will help assess the relevance of VA gain comparisons across trials.
Methods: A correlation analysis was performed between mean baseline VA and VA gain at month 12 for 1,616 diabetic macular edema patients across nine randomized clinical trials (RESOLVE, RISE, RIDE, RESTORE, RETAIN, DRCR.net Protocol I, DA VINCI, VIVID, VISTA) with anti-VEGF treatment regimens ranibizumab 0.5 mg and aflibercept 2 mg.
Results: The mean baseline VA ranged from 56.9 to 64.8 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. The mean VA gain at month 12 ranged from 6.8 to 13.1 ETDRS letters across trials. There was a strong inverse correlation between mean baseline VA and VA gain at month 12 (r=-0.85). The mean VA at 12 months plateaued at ~70 (68.5–73.0) ETDRS letters (20/40 Snellen VA equivalent) for the anti-VEGF treatment groups from all trials, regardless of dosing regimens and agents.
Conclusion: Cross-trial comparisons based on changes in best-corrected visual acuity should be done cautiously and only after adjusting for best-corrected visual acuity at baseline. Furthermore, the total VA afforded by treatment appears to be subject to a plateau effect, which warrants further exploration.
Keywords: aflibercept, anti-vascular endothelial growth factor, best-corrected visual acuity, cross-trial comparison, diabetic macular edema, ranibizumab
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