Universität zu Köln

Ziemssen, Focke ORCID: 0000-0002-3873-0581, Wachtlin, Joachim, Kuehlewein, Laura, Gamulescu, Maria-Andreea, Bertelmann, Thomas, Feucht, Nikolaus, Voegeler, Jessica, Koch, Mirja, Liakopoulos, Sandra, Schmitz-Valckenberg, Steffen and Spital, Georg (2018). Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany. Diabetes Ther., 9 (6). S. 2271 - 2290. HEIDELBERG: SPRINGER HEIDELBERG. ISSN 1869-6961

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Abstract

IntroductionThe prospective, non-interventional OCEAN study examined the use of intravitreal ranibizumab injections for the treatment of diabetic macular oedema (DME) in a real-world setting in Germany.MethodsAdults with DME receiving 1ranibizumab (0.5mg) injections were recruited by 250ophthalmologists. Best-corrected visual acuity (VA) testing, imaging and treatments were performed according to the investigators' routine practice and documented over 24months.ResultsThe full analysis set included 1226 participants. Mean baseline VA was 60.6 [95% CI: 59.7; 61.5] Early Treatment Diabetic Retinopathy Study letters. VA improved by 15letters in 21.5% and 23.5% of the participants at 12months and 24months, respectively. They received a mean number of 4.42 [95% CI: 4.30; 4.54] injections in the first year and 5.52 [95% CI: 5.32; 5.73] injections over 24months, which was markedly lower than in clinical trials. Only 33.4% of the participants received an upload with four initial monthly injections as recommended by the German ophthalmologic societies. Time-to-event analyses that account for missing data inherent to a non-interventional study design demonstrated that participants receiving 7injections in the first year had a faster response, but the duration of the response was shorter compared to the subgroups receiving 1-3 and 4-6injections. Serious adverse events were reported for 143/1250 (11.4%) participants in the safety population.ConclusionUnder-treatment is a major problem of DME anti- vascular endothelial growth factor therapy under real life conditions. Despite fewer injections given compared to randomised controlled trials with a consequently reduced overall mean visual gain, a profound functional improvement (15letters) was achieved over 2years in 23.5% of eyes with DME.Trial Registration NumberNCT02194803, ClinicalTrials.gov.FundingNovartis Pharma GmbH, Nuremberg, Germany.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Ziemssen, Focke UNSPECIFIED orcid.org/0000-0002-3873-0581 UNSPECIFIED Wachtlin, Joachim UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuehlewein, Laura UNSPECIFIED UNSPECIFIED UNSPECIFIED Gamulescu, Maria-Andreea UNSPECIFIED UNSPECIFIED UNSPECIFIED Bertelmann, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Feucht, Nikolaus UNSPECIFIED UNSPECIFIED UNSPECIFIED Voegeler, Jessica UNSPECIFIED UNSPECIFIED UNSPECIFIED Koch, Mirja UNSPECIFIED UNSPECIFIED UNSPECIFIED Liakopoulos, Sandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmitz-Valckenberg, Steffen UNSPECIFIED UNSPECIFIED UNSPECIFIED Spital, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-163611
DOI:	10.1007/s13300-018-0513-2
Journal or Publication Title:	Diabetes Ther.
Volume:	9
Number:	6
Page Range:	S. 2271 - 2290
Date:	2018
Publisher:	SPRINGER HEIDELBERG
Place of Publication:	HEIDELBERG
ISSN:	1869-6961
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ANTI-VEGF TREATMENT; HEALTH-CARE RESEARCH; VISUAL-ACUITY; RANDOMIZED-TRIAL; DEFERRED LASER; OUTCOMES; DEGENERATION; PATTERNS; PROMPT Multiple languages Endocrinology & Metabolism Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/16361