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

• DOI: 10.1007/s13300-018-0513-2
• Publication Date: 2018-10-04T16:19:05Z
• Authors: Focke Ziemssen; Joachim Wachtlin; Laura Kuehlewein; Maria-Andreea Gam...; Thomas Bertelmann; Nikolaus Feucht; Jessica Voegeler; Mirja Koch; Sandra Liakopoulos; Steffen Schmitz-V...; Georg Spital
• Keywords: Diabetic macular edema

The prospective, non-interventional OCEAN study examined the use of intravitreal ranibizumab injections for treatment diabetic macular oedema (DME) in a real-world setting Germany.Adults with DME receiving ≥ 1 (0.5 mg) were recruited by 250 ophthalmologists. Best-corrected visual acuity (VA) testing, imaging and treatments performed according to investigators' routine practice documented over 24 months.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. improved 15 letters 21.5% 23.5% participants at 12 months months, respectively. They received mean number 4.42 4.30; 4.54] first year 5.52 5.32; 5.73] which markedly lower than clinical trials. Only 33.4% an upload four initial monthly as recommended German ophthalmologic societies. Time-to-event analyses that account missing data inherent design demonstrated 7 had faster response, but duration response shorter compared subgroups 1-3 4-6 injections. Serious adverse events reported 143/1250 (11.4%) safety population.Under-treatment is major problem anti- vascular endothelial growth factor therapy under real life conditions. Despite fewer given randomised controlled trials consequently reduced overall gain, profound functional improvement (≥ letters) achieved 2 years eyes DME.NCT02194803, ClinicalTrials.gov.Novartis Pharma GmbH, Nuremberg, Germany.