Evidence map›Paper›PMID 32727496›Full record

Trial reportBMC ophthalmology2020

Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema (ReCaLL): a single center, randomised, controlled, non-inferiority clinical trial.

Olga Furashova, Patrick Strassburger, Klio Ai Becker, Katrin Engelmann

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence 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 NCT02059772 (Evaluation of an Additional Therapeutic Approach to Diabetic Macular Edema by Combining Standard Therapy), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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.

NCT02059772 phase4unknown statusnot on this map

Evaluation of an Additional Therapeutic Approach to Diabetic Macular Edema by Combining Standard Therapy (Intravitreal Injection of a VEGF-inhibitor) With Micropulse Diode Laser Treatment in a Randomized, Controlled Proof of Concept Study

TypeinterventionalSponsorGWT-TUD GmbHRan2014 to 2017Enrolled25ConditionsDiabetic Macular EdemaArmsranibizumab, micropulse diode laser
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Efficacy of anti-VEGF monotherapy versus anti-VEGF therapy with subthreshold micropulse laser (SML) in the management of diabetic macular oedema (DMO): a systematic review and meta-analysis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Pooled it
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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

4 authors at 1 institution in 1 country.

Olga FurashovaDepartment of Ophthalmology, Klinikum Chemnitz gGmbH, Flemmingstrasse 2, 09116, Chemnitz, Germany. o.furashova@skc.de.ORCID http://orcid.org/0000-0002-1273-7005
Patrick StrassburgerDepartment of Ophthalmology, Klinikum Chemnitz gGmbH, Flemmingstrasse 2, 09116, Chemnitz, Germany.
Klio Ai BeckerHessemer MVZ, Augenmedizin Darmstadt, Martinspfad 72, 64285, Darmstadt, Germany.
Katrin EngelmannDepartment of Ophthalmology, Klinikum Chemnitz gGmbH, Flemmingstrasse 2, 09116, Chemnitz, Germany.
Klinikum Chemnitz · DE

Funding

Novartis Pharma None
6 · The paper itself

Abstract

backgroundTo evaluate if a combination therapy with micropulse diode laser (MPL) shows non-inferiority on visual acuity (BCVA) within 12 months in comparison to standard therapy, i.e. intravitreal injection of ranibizumab alone.

settingInstitutional. Prospective randomized single-center trial.

methodsPatients with diabetic macular edema (DME) received three intravitreal injections of 0.5 mg ranibizumab during the upload phase and were then randomised 1:1 to receive either the same dosage of ranibizumab (0.5 mg) injections pro re nata alone (IVOM-Group; n = 9), or with two additional treatments with micropulse diode laser (IVOM+Laser-Group; n = 10). The primary endpoint was change in BCVA after 12 months. Secondary endpoints were change in central macular thickness and overall number of ranibizumab injections.

resultsBCVA increased significantly in both groups (IVOM: + 5.86, p < 0.001; IVOM+Laser: + 9.30; p < 0.001) with corresponding decrease in central macular thickness (IVOM: - 105 μm, p < 0.01; IVOM+Laser: - 125 μm; p < 0.01). Patients with additional laser treatment had better visual improvement (group comparison p = 0.075) and needed fewer ranibizumab injections (cumulative proportion of injections 9.68 versus 7.46 in IVOM-Group and IVOM+Laser-Group, respectively).

conclusionNon-inferiority of combination therapy in comparison to standard therapy alone could be demonstrated. Patients with additional laser therapy needed fewer ranibizumab injections.

trial registrationRegistered 10 February 2014 on ClinicalTrials.gov; NCT02059772 .

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAngiogenesis InhibitorsHumansIntravitreal InjectionsLasers, SemiconductorProspective StudiesRanibizumabTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor ADiabetic macular edemaIntravitreal injectionMicropulse diode laserRanibizumabVEGF inhibitor

Identifiers

PMID32727496
PMCPMC7391612
OpenAlexW3045533544

What OpenQuestion holds

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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.