Clinical Ophthalmology (Nov 2019)

Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study

  • Callizo J,
  • Ziemssen F,
  • Bertelmann T,
  • Feltgen N,
  • Vögeler J,
  • Koch M,
  • Eter N,
  • Liakopoulos S,
  • Schmitz-Valckenberg S,
  • Spital G

Journal volume & issue
Vol. Volume 13
pp. 2167 – 2179

Abstract

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Josep Callizo,1 Focke Ziemssen,2 Thomas Bertelmann,3 Nicolas Feltgen,3 Jessica Vögeler,4 Mirja Koch,4 Nicole Eter,5 Sandra Liakopoulos,6 Steffen Schmitz-Valckenberg,7 Georg Spital8 1Department of Ophthalmology, Georg-August University, Goettingen, Germany; 2Center for Ophthalmology, Eberhard Karl University of Tuebingen, Tuebingen, Germany; 3Georg-August-University Goettingen, University Eye Hospital, Goettingen, Germany; 4Novartis Pharma GmbH, Clinical Research, Nuremberg, Germany; 5Department of Ophthalmology, University of Muenster Medical Center, Muenster, Germany; 6Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany; 7Department of Ophthalmology, University of Bonn, Bonn, Germany; 8Augenzentrum Am St. Franziskus Hospital, Muenster, GermanyCorrespondence: Josep CallizoDepartment of Ophthalmology, Georg-August University, Robert-Koch-Str. 40, Goettingen 37075, GermanyTel +495513966776Fax +495513966787Email [email protected]: The non-interventional OCEAN study (NCT02194803) evaluated frequency and monitoring of ranibizumab injections for retinal vein occlusion (RVO) in routine practice in Germany.Methods: RVO patients (including branch and central RVO (BRVO/CRVO)) receiving ranibizumab were included. Best-corrected visual acuity (BCVA) testing, imaging and treatment were performed at the investigators’ discretion and documented over 24 months.Results: Overall, 744 RVO patients (27% BRVO, 16% CRVO, remaining unspecified RVO) were included. For 74% of patients, data were available for the 12-month visit and for 56% for the 24-month visit. Mean baseline BCVA was 52.0 Early Treatment for Diabetic Retinopathy Study (ETDRS) letters (BRVO: 55.9, CRVO: 43.9). BCVA improved rapidly within the first 3 months, reaching 64.3 letters at 12 months and 64.7 at 24 months. CRVO patients showed less improvement than those with BRVO. Patients received a median of 4 (5) injections over 12 (24) months, with 100% of patients receiving injections at baseline, 70% at Month 1 and 81% at Month 2. Overall, 40% of patients demonstrated a ≥15 letter increase within the first 3 months (42% BRVO, 46% CRVO). Patients with low initial BCVA (<50 letters) showed greater improvement than patients with higher baseline BCVA. Due to considerable loss to follow-up, the number of injections and optical coherence tomography (OCT) examinations were not associated with the change in BCVA.Conclusion: Patients with RVO in routine practice in Germany received fewer injections and fewer OCT examinations than in clinical trials. CRVO patients showed less and later improvement compared to BRVO patients.Keywords: retinal vein occlusion, RVO, macular edema, ranibizumab, anti-VEGF, real-world

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