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Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study

Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study
Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study
Background/Aims Prospective data on switching anti-vascular endothelial growth factors in patients with neovascular age-related macular degeneration (nAMD) who have previously shown no/partial response are limited. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistent/recurrent disease activity. Methods SAFARI (NCT02161575) was a 6-month, prospective, single-arm study conducted in the UK and Germany. Patients, meeting strict eligibility criteria for one of two subgroups (primary treatment failure or suboptimal treatment response), received 3 monthly intravitreal ranibizumab injections (0.5 mg). Thereafter, ranibizumab was administered pro re nata at monthly visits. The primary endpoint was change from baseline (CfB) to day 90 in central subfield retinal thickness (CSRT). Best-corrected visual acuity (BCVA) and retinal morphology parameters were assessed. Results One hundred patients were enrolled (primary treatment failure, 1; suboptimal treatment response, 99). In the overall population, there was a significant CfB in median CSRT of −30.75 µm (95% CI −59.50,–20.50; p<0.0001) to day 90. Improvements were also observed in other quantitative and qualitative optical coherence tomography parameters. In Early Treatment Diabetic Retinopathy Study letters assessed by category, 55% and 59% of patients gained 0–≥15 letters versus baseline at day 90 and day 180, respectively. However, mean improvements in BCVA (CfB) to each time point were small (≤2 letters). No new safety signals were identified. Conclusion Switching from aflibercept to ranibizumab led to a significant improvement in CSRT, with ~60% experiencing stabilised/improved BCVA. Therefore, patients with nAMD who have shown a suboptimal response to aflibercept may benefit from switching to ranibizumab.
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Pearce, Ian
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Gale, Richard P., Pearce, Ian, Eter, Nicole, Ghanchi, Faruque, Holz, Frank G., Schmitz-valckenberg, Steffen, Balaskas, Konstantinos, Burton, Ben J.L., Downes, Susan M., Eleftheriadis, Haralabos, George, Sheena, Gilmour, David, Hamilton, Robin, Lotery, Andrew J., Patel, Nishal, Prakash, Priya, Santiago, Cynthia, Thomas, Saju, Varma, Deepali, Walters, Gavin, Williams, Michael, Wolf, Armin, Zakri, Rosina H., Igwe, Franklin and Ayan, Filis (2019) Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study. British Journal of Ophthalmology. (doi:10.1136/bjophthalmol-2019-314251).

Record type: Article

Abstract

Background/Aims Prospective data on switching anti-vascular endothelial growth factors in patients with neovascular age-related macular degeneration (nAMD) who have previously shown no/partial response are limited. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistent/recurrent disease activity. Methods SAFARI (NCT02161575) was a 6-month, prospective, single-arm study conducted in the UK and Germany. Patients, meeting strict eligibility criteria for one of two subgroups (primary treatment failure or suboptimal treatment response), received 3 monthly intravitreal ranibizumab injections (0.5 mg). Thereafter, ranibizumab was administered pro re nata at monthly visits. The primary endpoint was change from baseline (CfB) to day 90 in central subfield retinal thickness (CSRT). Best-corrected visual acuity (BCVA) and retinal morphology parameters were assessed. Results One hundred patients were enrolled (primary treatment failure, 1; suboptimal treatment response, 99). In the overall population, there was a significant CfB in median CSRT of −30.75 µm (95% CI −59.50,–20.50; p<0.0001) to day 90. Improvements were also observed in other quantitative and qualitative optical coherence tomography parameters. In Early Treatment Diabetic Retinopathy Study letters assessed by category, 55% and 59% of patients gained 0–≥15 letters versus baseline at day 90 and day 180, respectively. However, mean improvements in BCVA (CfB) to each time point were small (≤2 letters). No new safety signals were identified. Conclusion Switching from aflibercept to ranibizumab led to a significant improvement in CSRT, with ~60% experiencing stabilised/improved BCVA. Therefore, patients with nAMD who have shown a suboptimal response to aflibercept may benefit from switching to ranibizumab.

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Accepted/In Press date: 12 July 2019
e-pub ahead of print date: 5 August 2019

Identifiers

Local EPrints ID: 433977
URI: http://eprints.soton.ac.uk/id/eprint/433977
ISSN: 0007-1161
PURE UUID: 5f68f2d1-b01d-4abe-873c-03360ea8eea7
ORCID for Andrew J. Lotery: ORCID iD orcid.org/0000-0001-5541-4305

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Date deposited: 09 Sep 2019 16:30
Last modified: 26 Nov 2021 02:47

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Contributors

Author: Richard P. Gale
Author: Ian Pearce
Author: Nicole Eter
Author: Faruque Ghanchi
Author: Frank G. Holz
Author: Steffen Schmitz-valckenberg
Author: Konstantinos Balaskas
Author: Ben J.L. Burton
Author: Susan M. Downes
Author: Haralabos Eleftheriadis
Author: Sheena George
Author: David Gilmour
Author: Robin Hamilton
Author: Nishal Patel
Author: Priya Prakash
Author: Cynthia Santiago
Author: Saju Thomas
Author: Deepali Varma
Author: Gavin Walters
Author: Michael Williams
Author: Armin Wolf
Author: Rosina H. Zakri
Author: Franklin Igwe
Author: Filis Ayan

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