[Treatment reality with ranibizumab in clinical routine use for patients with diabetic macular edema : 1‑year results of the German POLARIS cohort].
Behandlungsrealität mit Ranibizumab in der klinischen Routineanwendung bei Patienten mit diabetischem Makulaödem : 1-Jahres-Ergebnisse der deutschen POLARIS-Kohorte.
Anti-VEGF
Clinical practice
Diabetic retinopathy
Health care research
Intravitreal injections
Journal
Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft
ISSN: 1433-0423
Titre abrégé: Ophthalmologe
Pays: Germany
ID NLM: 9206148
Informations de publication
Date de publication:
Jul 2019
Jul 2019
Historique:
pubmed:
12
10
2018
medline:
28
7
2019
entrez:
12
10
2018
Statut:
ppublish
Résumé
Currently only few data are available on the treatment reality with ranibizumab in patients with diabetic macular edema (DME). POLARIS is an international observational study which included 983 patients who were treated with ranibizumab due to DME. The primary objective of the study was to investigate the influence of treatment and control intervals as well as resource utilization on the mean change in visual acuity. Secondary endpoints included the collation of disease activity monitoring in the clinical practice. This article describes the results of the German POLARIS population. The study was conducted in 8 European countries from October 2012 to January 2015. In Germany 220 patients were included in the study. Visual acuity improved by 4.3 letters within the first 3 months of treatment. At 12 months, visual acuity increased on average by 4.1 (SD ± 12.4) letters (approximately 1 line) for 168 patients enrolled in the efficacy analysis. Patients received an average of 4.5 (SD ± 1.9) injections, 10.3 (SD ± 6.3) visual acuity tests and 3.3 (SD ± 3.1) optical coherence tomography (OCT) examinations during the first year. Patients with ≤3 injections showed an average improvement in visual acuity by 2.7 letters which was less improvement compared to patients with >3 injections, who achieved an average improvement of 5.4 letters. There was a correlation between the number of injections and the visual acuity achieved. For Germany, the results of the POLARIS study indicate that despite a high number of visits, patients with DME are undertreated in clinical routine practice. The injection frequency in Germany was lower than in randomized clinical trials. Almost half of the patients received less than 4 injections in the first year of treatment and thus showed an undertreatment compared to the recommendations of German and international medical societies.
Sections du résumé
BACKGROUND
BACKGROUND
Currently only few data are available on the treatment reality with ranibizumab in patients with diabetic macular edema (DME).
MATERIAL AND METHODS
METHODS
POLARIS is an international observational study which included 983 patients who were treated with ranibizumab due to DME. The primary objective of the study was to investigate the influence of treatment and control intervals as well as resource utilization on the mean change in visual acuity. Secondary endpoints included the collation of disease activity monitoring in the clinical practice. This article describes the results of the German POLARIS population. The study was conducted in 8 European countries from October 2012 to January 2015.
RESULTS
RESULTS
In Germany 220 patients were included in the study. Visual acuity improved by 4.3 letters within the first 3 months of treatment. At 12 months, visual acuity increased on average by 4.1 (SD ± 12.4) letters (approximately 1 line) for 168 patients enrolled in the efficacy analysis. Patients received an average of 4.5 (SD ± 1.9) injections, 10.3 (SD ± 6.3) visual acuity tests and 3.3 (SD ± 3.1) optical coherence tomography (OCT) examinations during the first year. Patients with ≤3 injections showed an average improvement in visual acuity by 2.7 letters which was less improvement compared to patients with >3 injections, who achieved an average improvement of 5.4 letters. There was a correlation between the number of injections and the visual acuity achieved.
DISCUSSION
CONCLUSIONS
For Germany, the results of the POLARIS study indicate that despite a high number of visits, patients with DME are undertreated in clinical routine practice. The injection frequency in Germany was lower than in randomized clinical trials. Almost half of the patients received less than 4 injections in the first year of treatment and thus showed an undertreatment compared to the recommendations of German and international medical societies.
Identifiants
pubmed: 30306301
doi: 10.1007/s00347-018-0793-y
pii: 10.1007/s00347-018-0793-y
doi:
Substances chimiques
Angiogenesis Inhibitors
0
Vascular Endothelial Growth Factor A
0
Ranibizumab
ZL1R02VT79
Types de publication
Journal Article
Langues
ger
Pagination
631-639Références
Trans Am Ophthalmol Soc. 2009 Dec;107:311-24
pubmed: 20126505
Lancet. 2010 Jul 10;376(9735):124-36
pubmed: 20580421
Ophthalmology. 2011 Apr;118(4):615-25
pubmed: 21459215
Ophthalmology. 2012 Apr;119(4):789-801
pubmed: 22330964
Ophthalmologe. 2013 Aug;110(8):740-5
pubmed: 23224125
Acta Ophthalmol. 2013 May;91(3):e243-4
pubmed: 23280048
Graefes Arch Clin Exp Ophthalmol. 2014 Apr;252(4):647-55
pubmed: 24424409
Ophthalmology. 2014 May;121(5):1092-101
pubmed: 24461586
Br J Ophthalmol. 2014 Oct;98(10):1333-7
pubmed: 24903670
Ophthalmology. 2014 Nov;121(11):2247-54
pubmed: 25012934
Br J Ophthalmol. 2015 Feb;99(2):220-6
pubmed: 25193672
N Engl J Med. 2015 Mar 26;372(13):1193-203
pubmed: 25692915
PLoS One. 2015 Jun 15;10(6):e0127188
pubmed: 26075604
Br J Ophthalmol. 2016 Jun;100(6):787-95
pubmed: 26453639
Eye Vis (Lond). 2015 Sep 30;2:17
pubmed: 26605370
Ophthalmology. 2016 Jun;123(6):1351-9
pubmed: 26935357
Br J Ophthalmol. 2016 Dec;100(12):1623-1628
pubmed: 27030279
Eye (Lond). 2016 Aug;30(8):1063-71
pubmed: 27197868
Br J Ophthalmol. 2017 Mar;101(3):353-359
pubmed: 27215744
Am J Ophthalmol. 2016 Dec;172:51-57
pubmed: 27637784
Int J Retina Vitreous. 2016 Jul 11;2:16
pubmed: 27847634
Ophthalmologica. 2016;236(4):207-214
pubmed: 27898414
Ophthalmologica. 2017;237(4):185-222
pubmed: 28423385
Retina. 2018 Jun;38(6):1134-1144
pubmed: 28489692
Arch Ophthalmol. 1985 Dec;103(12):1796-806
pubmed: 2866759
Acta Ophthalmol. 2018 Dec;96(8):e942-e949
pubmed: 29696809