Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials

Pravin U Dugel; Jost Hillenkamp; Sobha Sivaprasad; Jessica Vögeler; Marie-Catherine Mousseau; Andreas Wenzel; Philippe Margaron; Ron Hashmonay; Pascale Massin

doi:10.2147/OPTH.S100764

Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials

Clin Ophthalmol. 2016 Jun 14:10:1103-10. doi: 10.2147/OPTH.S100764. eCollection 2016.

Authors

Pravin U Dugel¹, Jost Hillenkamp², Sobha Sivaprasad³, Jessica Vögeler⁴, Marie-Catherine Mousseau⁵, Andreas Wenzel⁶, Philippe Margaron⁶, Ron Hashmonay⁶, Pascale Massin⁷

Affiliations

¹ Retinal Consultants of Arizona LTD, Retinal Research Institute LLC, Phoenix, AZ, USA; USC Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
² Department of Ophthalmology, Julius-Maximilians University, Würzburg, Germany.
³ NIHR Biomedical Research Centre, Moorfields Eye Hospital, London; King's College Hospital, London, UK.
⁴ Novartis Pharma GmbH, Nürnberg, Germany.
⁵ Novartis Ireland Limited, Dublin, Ireland.
⁶ Novartis Pharma AG, Basel, Switzerland.
⁷ Department of Ophthalmology, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, Université Paris Diderot, Paris, France.

Abstract

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.