June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Real world evidence of retinal vein occlusion (RVO) patient treatment with ranibizumab in Germany based on the 24 months interim results of the non-interventional, observational PACIFIC study
Author Affiliations & Notes
  • Katrin Lorenz
    Department of Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Christos Haritoglou
    Augenklinik Herzog Carl Theodor, Germany
  • Kristina Markova
    Augenklinik Herzog Carl Theodor, Germany
  • Berenice Rösler
    Novartis Pharma GmbH, Germany
  • Matthias Iwersen
    Novartis Pharma GmbH, Germany
  • Ulrike Michel
    Novartis Pharma GmbH, Germany
  • Bianca Apitzsch
    Augenzentrum am Johannisplatz, Germany
  • Hüsnü Berk
    St. Elisabeth-Krankenhaus GmbH, Germany
  • Christian Karl Brinkmann
    Dietrich-Bonhoeffer-Klinikum, Germany
  • Ramin Khoramnia
    Augenklinik des Universitätsklinikums Heidelberg, Germany
  • Martin Scheffler
    Augenheilkunde Rhauderfehn, Germany
  • Jens Schrecker
    Rudolf Virchow Klinikum, Germany
  • Gregor Schwert
    MVZ Beckum, Germany
  • Focke Ziemssen
    Universitäts-Augenklinik, Germany
  • Footnotes
    Commercial Relationships   Katrin Lorenz, Isarna, Boehringer Ingelheim, Novartis (C), Novartis, Isarna, Mylan (R), Novartis,Roche, Kanghong, Bayer, Alimera, Mylan (F); Christos Haritoglou, Novartis, Bayer, Allergan, Alimera (R); Kristina Markova, Novartis (R); Berenice Rösler, Novartis (E); Matthias Iwersen, Novartis (E); Ulrike Michel, Novartis (E); Bianca Apitzsch, None; Hüsnü Berk, None; Christian Brinkmann, Alimera (R), Allergan, Alcon, Novartis (F); Ramin Khoramnia, Novartis, Roche,Bayer, Alimera,Allergan (R), Novartis, Roche,Bayer, Alimera, Kanghong (F); Martin Scheffler, Novartis (R); Jens Schrecker, None; Gregor Schwert, Novartis (R); Focke Ziemssen, Alimera, Allergan, Bayer, Boehringer Ingelheim, Genentech/Roche, MSD, Novartis, NovoNordisk, Optos (C), Allergan, Biogen, Clearside, Genentech/Roche, Novartis, Sanofi Aventis (R)
  • Footnotes
    Support  Grant by Novartis Pharma GmbH
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 1310. doi:
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      Katrin Lorenz, Christos Haritoglou, Kristina Markova, Berenice Rösler, Matthias Iwersen, Ulrike Michel, Bianca Apitzsch, Hüsnü Berk, Christian Karl Brinkmann, Ramin Khoramnia, Martin Scheffler, Jens Schrecker, Gregor Schwert, Focke Ziemssen; Real world evidence of retinal vein occlusion (RVO) patient treatment with ranibizumab in Germany based on the 24 months interim results of the non-interventional, observational PACIFIC study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):1310.

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

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Abstract

Purpose : The PACIFIC study aims to describe the current state of ranibizumab patient care across several indications including neovascular AMD, diabetic macula edema, branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO) and other choroidal neovascularization in Germany, the Netherlands and Switzerland. Here, we will focus on the RVO subgroup within the German cohort.

Methods : The PACIFIC study is a non-interventional, open label, multi-centric study aiming to collect real world evidence regarding the use of ranibizumab. 4,553 patients were recruited in Germany across 169 centers and followed for up to 24 months. We present data of 24 months RVO treatment with ranibizumab (362 BRVO and 259 CRVO patients) in a real-life setting, with a focus on treatment outcome and therapy schemes applied.

Results : The percentage of female patients were 51,7% and 45,2% in BRVO and CRVO, respectively. The entire population presented with a mean age of 70.8 and 71.7 years. Most patients were covered by public health insurance (BRVO: 81,2%; CRVO: 85,3%) and almost half of the patients were treatment-naïve (T-N) (BRVO: 46,4%; CRVO 46,7%). Mean BCVA at baseline was 58,2 (± 19,1) and 46,9 (± 26,0) letters for T-N BRVO and CRVO patients, respectively. After 24 months patients demonstrated a mean BCVA of 66,3 (± 27,6; BRVO) or 59,7 (± 30,4; CRVO) letters. An improvement of more than 15 letters was seen in 29,8% (BRVO) versus 36,4% (CRVO) of T-N patients. The decision to re-inject was most frequently based on OCT alone or OCT with BCVA assessment, rather than on BCVA assessment alone. “Fixed” treatment was the intended therapy scheme for most T-N patients in both, BRVO (54,2%) and CRVO (55,4%). During the observational period, however, the actual performed treatment appeared to shift towards a “monitor and extend” regimen (96.77% and 96.30% for BRVO and CRVO patients respectively).

Conclusions : We present data based on an interim analysis of the PACIFIC study, which provides real world evidence regarding the treatment of RVO patients with ranibizumab in Germany. Changes in visual acuity and preferences in therapy schemes used for German RVO patients will be discussed. These novel findings provide insights into how the implementation of ranibizumab treatment impacts visual outcomes for RVO patients.

This is a 2020 ARVO Annual Meeting abstract.

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