Evidence map›Paper›PMID 32450838›Full record

Trial reportBMC ophthalmology2020

Impact of intravitreal aflibercept dosing regimens in treatment-naïve patients with neovascular age-related macular degeneration: 2-year results of RAINBOW.

Michel Weber, Marcel Dominguez, Florence Coscas, Céline Faure, Stéphanie Baillif, Laurent Kodjikian, Salomon-Yves Cohen

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC 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 NCT02279537 (A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
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.

NCT02279537 completednot on this map

A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept

TypeobservationalSponsorBayerRan2014 to 2019Enrolled593ConditionsWet Macular DegenerationArmsAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Article
  2. Aflibercept 2 mg for Neovascular Age-Related Macular Degeneration: XTEND at 3 Years.Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde · 2026
    Observational
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. Final 4-year results of the RAINBOW real-world study: intravitreal aflibercept dosing regimens in France in treatment-naïve patients with neovascular age-related macular degeneration.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
    Observational
  9. Article
  10. Article
  11. Observational
  12. Review
  13. Article
  14. Article
  15. Review
  16. Trends in Real-World Neovascular AMD Treatment Outcomes in the UK.Clinical ophthalmology (Auckland, N.Z.) · 2020
    Review
  17. Anti-VEGF therapy - a new hope in AMD treatment.Romanian journal of ophthalmology
    Review
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

7 authors.

Michel WeberCHU Hôtel-Dieu, 44000, Nantes, France. weber.michel@bbox.fr.
Marcel DominguezCentre Rétine Galien, Bordeaux, France.
Florence CoscasCentre Odéon, Paris, France.
Céline FaureClinique Saint Martin, Ramsay Générale de Santé, Caen, France.
Stéphanie BaillifCHU Nice, Hôpital Pasteur 2, Nice, France.
Laurent KodjikianCroix-Rousse University Hospital, Hospices Civils de Lyon, University of Lyon I, Lyon, France.
Salomon-Yves CohenCentre d'Imagerie Et de Laser, Paris, France.

Funding

Bayer HealthCare SAS n/a
6 · The paper itself

Abstract

backgroundTo review treatment outcomes from real-world data of patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) injection.

methodsRAINBOW (ClinicalTrials.gov, NCT02279537) is an ongoing, observational, 4-year study to monitor the effectiveness and safety of IVT-AFL in patients with nAMD in clinical practice in France. Treatment-naïve patients diagnosed with nAMD who had been prescribed IVT-AFL by their treating physician were eligible. The regimens of interest were regular treatment interval cohort (patients who received three initial monthly IVT-AFL injections followed by regular injections every 2 months) and two irregular treatment interval cohorts (with and without three initial monthly injections). Here we describe results at 24 months in patients according to IVT-AFL treatment regimen.

resultsThe mean change in best-corrected visual acuity (BCVA) with IVT-AFL from baseline to 24 months was + 3.0 letters in the overall population (P < 0.05 vs baseline). The mean change was positive for the regular and irregular treatment interval cohorts with initial doses (+ 4.9 and + 4.0 letters, respectively; P < 0.05 vs baseline) and negative for the irregular treatment interval cohort without initial doses (- 2.5 letters; P = 0.365 vs baseline) at 24 months. The mean overall number of IVT-AFL injections over 12 and 24 months was 6.0 and 8.8, respectively. The most common ocular adverse events were lack of efficacy (6.3%), vitreous floaters (2.7%), and increased lacrimation (1.7%).

conclusionsIn the real-world RAINBOW study, visual outcomes observed at 24 months were consistent with results from the primary endpoint at 12 months. In this study, treatment-naïve patients who received three initial IVT-AFL doses and regular IVT-AFL treatment over the first 24 months experienced better visual outcomes than patients who received no initial doses and an irregular treatment regimen.

trial registrationwww.ClinicalTrials.gov (NCT02279537). Registered 29 October 2014.

Indexed as

AgedAged, 80 and overAngiogenesis InhibitorsChoroidal NeovascularizationFemaleFollow-Up StudiesHumansIntravitreal InjectionsMaleReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AVisual AcuityWet Macular DegenerationafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AVEGFA protein, humanFranceIntravitreal afliberceptNeovascular age-related macular degenerationObservationalReal-world

Identifiers

PMID32450838
PMCPMC7249443

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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.