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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

Authors
  • Furashova, Olga1
  • Strassburger, Patrick1
  • Becker, Klio Ai2
  • Engelmann, Katrin1
  • 1 Klinikum Chemnitz gGmbH, Flemmingstrasse 2, Chemnitz, 09116, Germany , Chemnitz (Germany)
  • 2 Hessemer MVZ, Augenmedizin Darmstadt, Martinspfad 72, Darmstadt, 64285, Germany , Darmstadt (Germany)
Type
Published Article
Journal
BMC Ophthalmology
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Jul 29, 2020
Volume
20
Issue
1
Identifiers
DOI: 10.1186/s12886-020-01576-w
Source
Springer Nature
Keywords
License
Green

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.

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