Evidence map›Paper›PMID 29090846›Full record

Trial reportActa ophthalmologica2018

The RELATION study: efficacy and safety of ranibizumab combined with laser photocoagulation treatment versus laser monotherapy in NPDR and PDR patients with diabetic macular oedema.

Gabriele E Lang, Sandra Liakopoulos, Jessica Vögeler, Claudia Weiß, Georg Spital, Maria-Andreea Gamulescu, Chris Lohmann, Peter Wiedemann

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Acta ophthalmologica, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
0.7field-weighted citation impact, top 28% 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.

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

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. A systematic review and meta-analysis of the effect of intravitreal VEGF inhibitors on cardiorenal outcomes.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
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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

8 authors at 7 institutions in 2 countries.

Gabriele E LangDepartment of Ophthalmology, University of Ulm, Ulm, Germany.
Sandra LiakopoulosCologne Image Reading Center, Center for Ophthalmology, University of Cologne, Cologne, Germany.
Jessica VögelerNovartis Pharma GmbH, Nuremberg, Germany.
Claudia WeißNovartis Pharma GmbH, Nuremberg, Germany.
Georg SpitalSt. Franziskus Hospital Münster, Münster, Germany.
Maria-Andreea GamulescuDepartment of Ophthalmology, University Hospital Regensburg, Regensburg, Germany.
Chris LohmannDepartment of Ophthalmology, University Teaching Hospital, Munich, Germany.
Peter WiedemannDepartment of Ophthalmology, University of Leipzig, Leipzig, Germany.
Novartis (Germany) · DELeipzig University · DESt. Franziskus Hospital · DEUniversität Ulm · DEUniversity Hospital Regensburg · DEUniversity of Cologne · DEUniversity Teaching Hospital · ZM

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess efficacy and safety of intravitreal ranibizumab 0.5 mg plus laser (COMBI) versus laser monotherapy (LASER) in patients with visual impairment due to diabetic macular oedema (DME) in either nonproliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) and to analyse the relevance of inner versus outer retinal thickness.

methodsIn this double-masked, multicentre phase IIIb study, patients (N = 128) were randomized (2:1) to receive COMBI (n = 85) versus LASER (n = 43). Patients received four initial monthly injections of ranibizumab 0.5 mg (COMBI) or sham (LASER) followed by pro re nata (PRN) injections. In both groups, patients received laser at baseline and additional laser at 3 monthly intervals, as needed. The study was started in 2010 and was prematurely terminated due to approval of ranibizumab for DME.

resultsThe least squares (LS) mean change in mean best-corrected visual acuity (BCVA) from baseline to month 12 was higher in the COMBI (6.5) versus LASER (2.3) group (LS mean difference: 4.2 [95% CI 0.9; 7.4] letters, p = 0.01, primary end-point). There was also a tendency in the same direction for the subgroup of 26 patients with PDR (LS mean difference 14.7, p = 0.11). Mean central retinal thickness decreased by 107.3 μm in the COMBI group and by 80.3 μm in the LASER group from baseline to month 12 (p = 0.28). Ranibizumab was well tolerated.

conclusionThis study showed that ranibizumab plus laser is a valuable treatment option for the management of DME. Patients with DME in PDR might also benefit from combined therapy compared to laser alone.

Indexed as

Angiogenesis InhibitorsDiabetic RetinopathyDouble-Blind MethodFemaleFluorescein AngiographyFundus OculiHumansIntravitreal InjectionsLaser CoagulationMacular EdemaMaleMiddle AgedRanibizumabTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor Adiabetic macular oedemaintravitreal injectionslaser monotherapyproliferative diabetic retinopathyranibizumabvisual acuity

Identifiers

PMID29090846
PMCPMC5947710
OpenAlexW2765835786

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.