Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany.

Autor: Ziemssen, Focke, Wachtlin, Joachim, Kuehlewein, Laura, Gamulescu, Maria-Andreea, Bertelmann, Thomas, Feucht, Nikolaus, Voegeler, Jessica, Koch, Mirja, Liakopoulos, Sandra, Schmitz-Valckenberg, Steffen, Spital, Georg, for the OCEAN study group
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Zdroj: Diabetes Therapy; Dec2018, Vol. 9 Issue 6, p2271-2289, 19p
Abstrakt: Introduction: The 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.Methods: Adults with DME receiving ≥ 1 ranibizumab (0.5 mg) injections were recruited by 250 ophthalmologists. Best-corrected visual acuity (VA) testing, imaging and treatments were performed according to the investigators’ routine practice and documented over 24 months.Results: The 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 ≥ 15 letters in 21.5% and 23.5% of the participants at 12 months and 24 months, 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 24 months, 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 ≥ 7 injections in the first year had a faster response, but the duration of the response was shorter compared to the subgroups receiving 1-3 and 4-6 injections. Serious adverse events were reported for 143/1250 (11.4%) participants in the safety population.Conclusion: Under-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 (≥ 15 letters) was achieved over 2 years in 23.5% of eyes with DME.Trial Registration Number: NCT02194803, ClinicalTrials.gov.Funding: Novartis Pharma GmbH, Nuremberg, Germany. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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