July 2018
Volume 59, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2018
Interim results of the German diabetic macula edema (DME) population within the PACIFIC study
Author Affiliations & Notes
  • Kristina Markova
    Augenklinik Herzog Carl Theodor, München, Germany
  • Christos Haritoglou
    Augenklinik Herzog Carl Theodor, München, Germany
  • Matthias Iwersen
    Novartis Pharma GmbH, Nürnberg, Germany
  • Ulrike Michel
    Novartis Pharma GmbH, Nürnberg, Germany
  • Florian Diwischek
    Novartis Pharma GmbH, Nürnberg, Germany
  • Matthias Grüb
    Praxis Prof. Dr. med. Matthias Grüb & Kollegen, Breisach am Rhein, Germany
  • Focke Ziemssen
    Universitäts-Augenklinik Tübingen, Tübingen, Germany
  • Footnotes
    Commercial Relationships   Kristina Markova, Novartis (R); Christos Haritoglou, Allergan (C), Allergan (R), Bayer (R), Novartis (C), Novartis (R); Matthias Iwersen, Novartis (E); Ulrike Michel, Novartis (E); Florian Diwischek, Novartis (E); Matthias Grüb, Bayer Healthcare (R), Novartis (R); Focke Ziemssen, Alcon (R), Alimera (C), Allergan (C), Allergan (R), Bayer Healthcare (C), Bayer Healthcare (R), Biogen (R), Boehringer-Ingelheim (C), Novartis (C), Novartis (R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 3612. doi:
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      Kristina Markova, Christos Haritoglou, Matthias Iwersen, Ulrike Michel, Florian Diwischek, Matthias Grüb, Focke Ziemssen; Interim results of the German diabetic macula edema (DME) population within the PACIFIC study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3612.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Randomized controlled trials have already proven the favourable effect of vascular endothelial growth factor (VEGF) inhibition with ranibizumab in several indications including DME. However, few prospective studies have investigated DME patients in a real-life setting. PACIFIC is an observational, non-interventional study, conducted to evaluate ranibizumab treatment patterns in real-life conditions according to local routine clinical practice in all approved indications. Here, we present an interim sub-analysis of the German DME population.

Methods : The PACIFIC study is observing up to 5,500 patients in 250 sites for a 24-month period. All patients are treated as per the local practice of the participating centers. Of the 2,607 German patients from the 12-month interim analysis, 493 have been diagnosed with DME (41.4% female/58.6% male) with an average age of 66.7 years. The following data from this cohort were recorded and analyzed: number of visits, best corrected visual acuity (BCVA), number of injections and the use of diagnostic tools and adverse events.

Results : BCVA at baseline was 62.7 (± 15.9 letters) for treatment-naive (tn) patients and 66.1 (± 17.0 letters) for pretreated (pt) patients. 78.5% of tn-patients and 70.2% of pt-patients were examined by optical coherence tomography (OCT) at baseline. Patients had an average of 5.6 BCVA assessments (in both groups) and 2.8 (tn) and 3.3 (pt) OCT examinations during the first year. The mean number of days between first visual acuity visit and first injection was 10.4 (±14.5; median 6.0 days) for tn patients and 15.0 (±18.1; median 8.0 days) for pt patients. After 12 months with an average of 4.7 (tn) versus 4.3 (pt) injections, tn and pt patients gained 8.3 (±12.0) letters and 2.9 (±11.0) letters, respectively compared with baseline. The safety profile of ranibizumab was consistent with previously reported DME studies with no new safety findings.

Conclusions : By observing local routine clinical practice, the non-interventional PACIFIC study will provide a better understanding of how patients are treated with ranibizumab in real-life settings. Favorable effects of ranibizumab on the visual acuity of DME patients were detected after 12 months in an interim analysis of the real-life PACIFIC trial.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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