Impact of retinal thickness fluctuations with ranibizumab versus aflibercept in neovascular age-related macular degeneration (SALT) - 12-month results from a multicentre, randomised, phase IV trial

Sep 29, 2026

Background/aims compare fluctuations of central subfield retinal thickness (CSRT) in neovascular age-related macular degeneration patients treated with ranibizumab pro re nata versus aflibercept bimonthly therapy over 12 months in a prospective phase IV multicentre randomized study. Methods assessed CSRT stability between months 3 and 6 and correlated stability with functional outcomes at month 12 using spectral-domain optical coherence tomography. Results showed numerical regimen differences, with a predefined adjusted analysis favoring ranibizumab and no CSRT fluctuation–BCVA correlation at month 12. Adverse events were low.

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CategoryHealthcare

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Retina Clinical science Impact of retinal thickness fluctuations with ranibizumab versus aflibercept in neovascular agerelated macular degeneration (SALT): 12-month results from a multicentre, randomised, phase IV trial Hansjuergen T Agostini, 1 Rufino Silva ,2 Frank G Holz,3 Michael Larsen,4 Lebriz Altay,5,6 Eric H Souied,7 Claudia Quiering,8 Uwe Rose,9 Sandra Liakopoulos , 10 on behalf of SALT study group ► Additional supplemental material is published online only. To view, please visit the journal online ([https://doi.org/](https://doi.org/)[ ](https://doi.org/)[10.1136/bjo-2024-326526](10.1136/bjo-2024-326526)) . For numbered affiliations see end of article. Correspondence to Hansjuergen T Agostini; hansjuergen.agostini@uniklinik[freiburg.de](freiburg.de) Presented at the European Society of Retina Specialists (EURETINA) 2018 congress, Vienna, Austria. Received 20 September 2024 Accepted 1 July 2025 © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. To cite: Agostini HT, Silva R, Holz FG, et al. Br J Ophthalmol Epub ahead of print: [please include Day Month Year] . doi:10 . 1136/ bjo-2024-326526 ABSTRACT Background/aims To compare fluctuations of central subfield retinal thickness (CSRT) in patients with neovascular age-related macular degeneration undergoing ranibizumab pro re nata versus aflibercept bimonthly treatment in a prospective 12 month, phase IV, randomised, multicentre study. Methods Ranibizumab was administered according to best-corrected visual acuity (BCVA) and/or disease activity detected on spectral domain optical coherence tomography. Aflibercept was administered at three initial monthly visits followed by bimonthly treatment. CSRT stability was evaluated between months 3 and 6. CSRT stability was compared between groups and correlated with functional outcomes at month 12. Results Fluctuations of CSRT showed a least-squares (LS) mean (95% CI) difference of −4.12 (−10 .22 to 1.98) µm between ranibizumab (25 . 16 (20 .09 to 30 . 24)µm) and aflibercept groups (29.28 (24.14 to 34.43) µm)(p=0 . 1850) . A predefined analysis of retinal stability, adjusted for baseline CSRT, showed a LS mean (95% CI) difference of −6.53 (−12 .47 to −0.58 µm) in favour of ranibizumab (23 . 53 (18 . 58 to 28 .49) µm) versus aflibercept (30 .06 (25 .04 to 35 .07) µm) (p=0 .0315) . Pearson’s correlation coefficient demonstrated no correlation between the mean amplitude of CSRT fluctuation between months 3 and 6, and BCVA at month 12 (r = −0 .0888) . Adverse event rates were low. Conclusions Numerical differences in retinal thickness fluctuations between months 3 and 6 were detected between treatment regimens. While the presence of fluctuations has previously been shown to have a negative impact on functional outcomes, our data showed no correlation between the mean amplitude of fluctuations and functional outcomes at month 12. INTRODUCTION Age-related macular degeneration (AMD) is a leading cause of severe and irreversible vision loss, affecting approximately 10%–13% of adults aged more than 65 years.1 2 Most cases of severe vision loss in AMD are observed inpatients with neovascular AMD (nAMD),3 4 eventhough this type accounts for only 10%–12% WHAT IS ALREADY KNOWN ON THIS TOPIC | ⇒ Retinal thickness fluctuations occur in patients treated with antivascular endothelial growth factor treatment and may have a negative impact on functional outcome.
WHAT THIS STUDY ADDS | | --- | | ⇒ The amplitude of retinal thickness fluctuations between months 3 and 6 has no influence on functional outcome at month 12.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY | ⇒ The study adds to the understanding of retinal thickness fluctuations and their influence on functional outcomes. of all AMD cases.5 6 Antivascular endothelial growth factor (anti-VEGF) agents are currently considered the stan

FAQs

What is the main goal of the SALT 12-month study?

To compare how CSRT fluctuates between months 3 and 6 in patients with neovascular age-related macular degeneration treated with ranibizumab PRN versus aflibercept bimonthly, and to relate stability to functional outcomes at month 12.

How were ranibizumab and aflibercept administered?

Ranibizumab was given according to best-corrected visual acuity and/or disease activity on spectral domain optical coherence tomography, whereas aflibercept used three initial monthly visits followed by bimonthly treatment.

Did retinal thickness fluctuation correlate with functional outcomes at month 12?

The study found no correlation between the mean amplitude of CSRT fluctuation (months 3 to 6) and BCVA at month 12, despite earlier evidence that fluctuations can negatively affect outcomes.

Sep 29, 2026

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