July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Observation of ranibizumab treatment in real-life conditions – an interim analysis of the myopic choroidal neovascularization (mCNV) population within the observational, non-interventional PACIFIC study
Author Affiliations & Notes
  • Kristina Markova
    Augenklinik Herzog Carl Theodor, Munich, Germany
  • Christos Haritoglou
    Augenklinik Herzog Carl Theodor, Munich, Germany
  • Matthias Iwersen
    Novartis Pharma GmbH, Germany
  • Ulrike Michel
    Novartis Pharma GmbH, Germany
  • Martina Junge
    Novartis Pharma GmbH, Germany
  • Peter Geuking
    Novartis Pharma Switzerland AG, Switzerland
  • Katrin Lorenz
    Augenklinik und Poliklinik der Universitätsmedizin Mainz, Germany
  • Thomas Ach
    Augenklinik und Poliklinik des Universitätsklinikums Würzburg, Germany
  • Ramin Khoramnia
    Augenklinik des Universitätsklinikums Heidelberg, Germany
  • Andreas Schmidt
    Augenzentrum Andernach, Germany
  • Judith Becker
    Augenärzte im Basteicenter, Germany
  • Erik Beeke
    visual eins, MVZ für Augenheilkunde und Anästhesie GmbH, Germany
  • Mathias Müller-Holz
    Augenärztliche Gemeinschaftspraxis Dr. Müller-Holz & Dr. Riedel, Germany
  • Daniel Barthelmes
    Universitäts Spital Zürich, Switzerland
  • Focke Ziemssen
    Universitäts-Augenklinik 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); Martina Junge, Novartis (E); Peter Geuking, Novartis (E); Katrin Lorenz, Aerie Pharmaceuticals (F), Alcon (F), Alimera (F), Allergan (F), Bayer (F), Bioeq (F), Boehringer Ingelheim (C), Boehringer Ingelheim (F), Chroma Pharma (C), Chroma Pharma (F), Chroma Pharma (R), Isarna Therapeutics (C), Isarna Therapeutics (F), Novartis (C), Novartis (F), Pfizer (F), Quark Pharmaceuticals (F), Regeneron (F), Roche (C), Roche (F), Santen (F), Shire (F), Synteract HCR (C), Thea (F), Thermogenics (F); Thomas Ach, Alimera (R), Allergan (R), Macregen Inc. (I), Novartis (R), Roche (C); Ramin Khoramnia, Alcon (R), Alimera (R), Allergan (R), Bayer Healthcare (R), Novartis (R); Andreas Schmidt, Novartis (R); Judith Becker, Novartis (R); Erik Beeke, Novartis (R); Mathias Müller-Holz, Novartis (R); Daniel Barthelmes, Alcon (C), Bayer (F), Bayer (R), Novartis (F), Novartis (R); Focke Ziemssen, Alcon (R), Alimera (C), Allergan (C), Allergan (R), Bayer Healthcare (C), Bayer Healthcare (R), Biogen (R), Boehringer-Ingelheim (C), Clearside (R), MSD (C), Novartis (C), Novartis (R), NovoNordisk (C), Roche (C), Roche (R)
  • Footnotes
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Investigative Ophthalmology & Visual Science July 2019, Vol.60, 4320. doi:https://doi.org/
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      Kristina Markova, Christos Haritoglou, Matthias Iwersen, Ulrike Michel, Martina Junge, Peter Geuking, Katrin Lorenz, Thomas Ach, Ramin Khoramnia, Andreas Schmidt, Judith Becker, Erik Beeke, Mathias Müller-Holz, Daniel Barthelmes, Focke Ziemssen; Observation of ranibizumab treatment in real-life conditions – an interim analysis of the myopic choroidal neovascularization (mCNV) population within the observational, non-interventional PACIFIC study. Invest. Ophthalmol. Vis. Sci. 2019;60(9):4320. doi: https://doi.org/.

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

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Abstract

Purpose : PACIFIC is an observational, non-interventional study of up to 5,500 patients in 211 sites for a 24-month period, conducted to evaluate ranibizumab treatment patterns in real-life conditions according to local routine clinical practice in all approved indicationsinGermany, Switzerland and the Netherlands. In the management of mCNV, clinical studies have demonstrated ranibizumab's efficacy and safety however, few prospective studies have investigated patients with mCNV in a real-life setting (PMID: 30158574). Here, we present an interim sub-analysis of the mCNV population enrolled in the PACIFIC study.

Methods : Of the 3,777 patients (61.4% female; mean age: 60.2±14.36 years), 60 (1.59%) had been diagnosed with mCNV. 50% of the mCNV population was either treatment-naïve or already pretreated at baseline. All patients were treated as per the local practice of the participating centers. Number of visits, best corrected visual acuity (BCVA), number of injections and the use of diagnostic tools (e.g. fluorescein angiography, optical coherence tomography (OCT)) and adverse events were recorded and analyzed.

Results : BCVA at baseline was 53.5±23.5 lettersfor treatment-naïve (tn) patients and 57.6±21.2letters for pretreated (pt) patients. 25/30 (83.3%) of tn-patients and 15/30 (50%) of pt-patients were examined by OCT at baseline.Patients had an average of 5.5 (tn) and 6.3 (pt) BCVA assessments and 3.7 (tn) and 3.6 (pt) OCT examinations during the first year.The mean number of days between first visual acuity visit and first injection was 9.6±12.6 (median 6.0) days for tn patients and 6.3±12.8 (median 0) days for pt patients. After 12 months with an average of 3.3 (tn) versus 2.4 (pt) injections, tn and pt patients gained 14.0±17.7 letters and 3.6±15.0 letters, respectively compared with baseline.The safety profile of ranibizumab was consistent with previously reported mCNV studies.

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 mCNV patients, with a greaterBCVA improvement for treatment-naïvepatients,were detected after 12 months in an interim analysis of the real-life PACIFIC study.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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