Evidence map›Paper›PMID 26149170›Full record

Trial reportBMC ophthalmology2015

Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study).

A M E Schauwvlieghe, G Dijkman, J M Hooymans, F D Verbraak, C B Hoyng, M G W Dijkgraaf, R Van Leeuwen, J R Vingerling, A C Moll, Reinier O Schlingemann

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
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

10 authors.

A M E SchauwvliegheDepartment of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. a.m.schauwvlieghe@amc.uva.nl.
G DijkmanDepartment of Ophthalmology, Leiden University Medical Centre, Leiden, The Netherlands. G.Dijkman@lumc.nl.
J M HooymansDepartment of Ophthalmology, University Medical Center Groningen, Groningen, The Netherlands. j.m.m.hooymans@ohk.umcg.nl.
F D VerbraakDepartment of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. f.d.verbraak@amc.uva.nl.
C B HoyngDepartment of Ophthalmology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. C.Hoyng@ohk.umcn.nl.
M G W DijkgraafClinical Research Unit, Academic Medical Center, Amsterdam, The Netherlands. m.g.dijkgraaf@amc.uva.nl.
R Van LeeuwenDepartment of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands. r.vanleeuwen@umcutrecht.nl.
J R VingerlingDepartment of Ophthalmology, Erasmus Medical Center, Rotterdam, The Netherlands. j.vingerling@erasmusmc.nl.
A C MollDepartment of Ophthalmology, VU University Medical Centre, Amsterdam, The Netherlands. a.moll@vumc.nl.
Reinier O SchlingemannDepartment of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. r.schlingemann@amc.uva.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effectiveness of ranibizumab in the treatment of diabetic macular edema has been proven with large clinical trials. For bevacizumab only two clinical trials have been published and a head-to-head comparison is lacking to date. However, if proved non-inferior to ranibizumab, use of the off-label bevacizumab could reduce costs enormously without a loss in visual acuity. A cost-effectiveness study has been designed to substantiate this hypothesis.

aimTo compare the effectiveness and costs of 1.25 mg of bevacizumab to 0.5 mg ranibizumab given as monthly intravitreal injections during 6 months in patients with diabetic macular edema. It is hypothesized that bevacizumab is non-inferior to ranibizumab regarding its effectiveness.

designThis is a randomized, controlled, double masked, clinical trial in 246 patients in seven academic trial centres in The Netherlands. OUTCOMES: The primary outcome measure is the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6. Secondary outcomes are the proportions of patients with a gain or loss of 15 letters or more or a BCVA of 20/40 or more at 6 months, the change in leakage on fluorescein angiography and the change in foveal thickness by optical coherence tomography at 6 months, the number of adverse events in 6 months, and the costs per quality adjusted life-year of the two treatments.

Indexed as

AdolescentAdultAngiogenesis InhibitorsBevacizumabDiabetic RetinopathyDouble-Blind MethodDrug CostsFemaleFluorescein AngiographyHumansIntravitreal InjectionsMacular EdemaMaleRanibizumabSurveys and QuestionnairesTomography, Optical CoherenceAngiogenesis InhibitorsBevacizumabRanibizumabVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID26149170
PMCPMC4491889

What OpenQuestion holds

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Registered trials

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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.