{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Ophthalmology, Medical Faculty, University of Freiburg, Freiburg, Germany"
      ],
      "name": "Hansjuergen T Agostini"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Hospital of the University of Coimbra, Coimbra, Portugal"
      ],
      "name": "Rufino Silva"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, University of Bonn, Bonn, Germany"
      ],
      "name": "Frank G Holz"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Michael Larsen"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, University of Cologne, Cologne, Germany",
        "Department of Ophthalmology, Uniklinik Koln, Koln, Germany"
      ],
      "name": "Lebriz Altay"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, Creteil, France"
      ],
      "name": "Eric H Souied"
    },
    {
      "affiliations": [
        "Novartis Germany, Nurnberg, Germany"
      ],
      "name": "Claudia Quiering"
    },
    {
      "affiliations": [
        "Novartis Pharma GmbH, Nurnberg, Germany"
      ],
      "name": "Uwe Rose"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Goethe-Universitat Frankfurt am Main, Frankfurt am Main, Germany"
      ],
      "name": "Sandra Liakopoulos"
    },
    {
      "affiliations": [],
      "name": "on behalf of SALT study group"
    }
  ],
  "title": "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",
  "uid": "ec90ac0c-b64d-5e57-9ee1-2f5d24631e02"
}
