Evidence map›Paper›PMID 31383649›Full record

Trial reportThe British journal of ophthalmology2020

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

Richard P Gale, Ian Pearce, Nicole Eter, Faruque Ghanchi, Frank G Holz, Steffen Schmitz-Valckenberg, Konstantinos Balaskas, Ben J L Burton, Susan M Downes, Haralabos Eleftheriadis and 15 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02161575 (A Phase IV, Prospective, Open-label, Uncontrolled, European Study in Patients With Neovascular Age-related Macular Degeneration), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.3field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02161575 phase4completednot on this map

A Phase IV, Prospective, Open-label, Uncontrolled, European Study in Patients With Neovascular Age-related Macular Degeneration (nAMD), Evaluating the Efficacy and Safety of Switching From Intravitreal Aflibercept to Ranibizumab 0.5mg.

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2017Enrolled103ConditionsNeovascular Age-related Macular DegenerationArmsRanibizumab
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 28 citations in OpenAlex.

  1. A randomized, open-label, multicenter study of switching to brolucizumab with or without a loading dose for patients with suboptimal anatomically controlled neovascular age-related macular degeneration-the FALCON study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022
    Trial
  2. Article
  3. Review
  4. Article
  5. Short-term outcomes of intravitreal faricimab for refractory neovascular age-related macular degeneration.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Article
  6. Intravitreal faricimab for neovascular age-related macular degeneration previously treated with traditional anti-VEGF compounds: a real-world prospective study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Article
  7. Long-term choroidal thickness changes based on the subtype of macular neovascularization in neovascular age-related macular degeneration (5-year follow-up).Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Outcomes after switching eyes that were stable on aflibercept to ranibizumab versus continuing aflibercept in neovascular age-related macular degeneration.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022
    Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Long-term switching between ranibizumab and aflibercept in neovascular age-related macular degeneration and polypoidal choroidal vasculopathy.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2020
    Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 2 countries.

Richard P GaleYork Teaching Hospital NHS Foundation Trust, York, UK richard.gale@york.nhs.uk.
Ian PearceRoyal Liverpool University Hospital, Liverpool, UK.
Nicole EterDepartment of Ophthalmology, University of Münster Medical Center, Münster, Germany.
Faruque GhanchiBradford Teaching Hospitals NHS Trust, Bradford, UK.
Frank G HolzGRADE Reading Center, Department of Ophthalmology, University of Bonn, Bonn, Germany.
Steffen Schmitz-ValckenbergGRADE Reading Center, Department of Ophthalmology, University of Bonn, Bonn, Germany.
Konstantinos BalaskasMoorfields Eye Hospital NHS Foundation Trust, London, UK.
Ben J L BurtonJames Paget University Hospitals NHS Foundation Trust, Great Yarmouth, UK.
Susan M DownesOxford University Hospitals NHS Foundation Trust, Oxford, UK.
Haralabos EleftheriadisKing's College London, London, UK.
Sheena GeorgeHillingdon Hospitals NHS Foundation Trust, Uxbridge, UK.
David GilmourNHS Greater Glasgow and Clyde, Glasgow, UK.
Robin Hamilton
Andrew J LoteryFaculty of Medicine, University of Southampton, Southampton, Hampshire, UK.
Nishal PatelEast Kent Hospitals University NHS Foundation Trust, Canterbury, UK.
Priya PrakashPrincess Alexandra Hospital NHS Trust, Harlow, UK.
Cynthia SantiagoAberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.
Saju ThomasCounty Durham and Darlington NHS Foundation Trust, Darlington, UK.
Deepali VarmaCity Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.
Gavin WaltersHarrogate and District NHS Foundation Trust, Harrogate, UK.
Michael WilliamsQueen's University Belfast, Belfast, UK.ORCID 0000-0002-5051-5921
Armin WolfUniversity of Munich, Munich, Germany.
Rosina H ZakriEast Kent Hospitals University NHS Foundation Trust, Canterbury, UK.
Franklin IgweNovartis Pharmaceuticals UK Ltd, Surrey, UK.
Filis AyanNovartis Pharmaceuticals UK Ltd, Surrey, UK.
East Kent Hospitals University NHS Foundation Trust · GBNovartis (United Kingdom) · GBUniversity of Bonn · DEYork Teaching Hospital NHS Foundation Trust · GBAberdeen Royal Infirmary · GBBradford Teaching Hospitals NHS Foundation Trust · GBCounty Durham and Darlington NHS Foundation Trust · GBHarrogate and District NHS Foundation Trust · GBHillingdon Hospitals NHS Foundation Trust · GBKing's College London · GBLudwig-Maximilians-Universität München · DEMoorfields Eye Hospital NHS Foundation Trust · GBNHS Greater Glasgow and Clyde · GBOxford University Hospitals NHS Trust · GBPrincess Alexandra Hospital NHS Trust · GBQueen's University Belfast · GBSouth Tyneside and Sunderland NHS Foundation Trust · GBUniversity of East Anglia · GBUniversity of Liverpool · GBUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsProspective 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.

methodsSAFARI (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.

resultsOne 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.

conclusionSwitching 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.

Indexed as

Drug SubstitutionAgedAged, 80 and overAngiogenesis InhibitorsChoroidal NeovascularizationFemaleFluorescein AngiographyFollow-Up StudiesGermanyHumansIntravitreal InjectionsMaleMiddle AgedProspective StudiesRanibizumabReceptors, Vascular Endothelial Growth FactorafliberceptAngiogenesis InhibitorsRanibizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AVEGFA protein, humanclinical trialdegenerationimagingmaculaneovascularisation

Identifiers

PMID31383649
PMCPMC7147176
OpenAlexW2966784084

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.