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

PURPOSE: 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-corre...

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Autores principales: Callizo, Josep, Ziemssen, Focke, Bertelmann, Thomas, Feltgen, Nicolas, Vögeler, Jessica, Koch, Mirja, Eter, Nicole, Liakopoulos, Sandra, Schmitz-Valckenberg, Steffen, Spital, Georg
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6847987/
https://www.ncbi.nlm.nih.gov/pubmed/31806930
http://dx.doi.org/10.2147/OPTH.S209253
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author Callizo, Josep
Ziemssen, Focke
Bertelmann, Thomas
Feltgen, Nicolas
Vögeler, Jessica
Koch, Mirja
Eter, Nicole
Liakopoulos, Sandra
Schmitz-Valckenberg, Steffen
Spital, Georg
author_facet Callizo, Josep
Ziemssen, Focke
Bertelmann, Thomas
Feltgen, Nicolas
Vögeler, Jessica
Koch, Mirja
Eter, Nicole
Liakopoulos, Sandra
Schmitz-Valckenberg, Steffen
Spital, Georg
author_sort Callizo, Josep
collection PubMed
description PURPOSE: 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.
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spelling pubmed-68479872019-12-05 Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study Callizo, Josep Ziemssen, Focke Bertelmann, Thomas Feltgen, Nicolas Vögeler, Jessica Koch, Mirja Eter, Nicole Liakopoulos, Sandra Schmitz-Valckenberg, Steffen Spital, Georg Clin Ophthalmol Original Research PURPOSE: 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. Dove 2019-11-07 /pmc/articles/PMC6847987/ /pubmed/31806930 http://dx.doi.org/10.2147/OPTH.S209253 Text en © 2019 Callizo et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Callizo, Josep
Ziemssen, Focke
Bertelmann, Thomas
Feltgen, Nicolas
Vögeler, Jessica
Koch, Mirja
Eter, Nicole
Liakopoulos, Sandra
Schmitz-Valckenberg, Steffen
Spital, Georg
Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study
title Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study
title_full Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study
title_fullStr Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study
title_full_unstemmed Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study
title_short Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study
title_sort real-world data: ranibizumab treatment for retinal vein occlusion in the ocean study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6847987/
https://www.ncbi.nlm.nih.gov/pubmed/31806930
http://dx.doi.org/10.2147/OPTH.S209253
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