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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2019
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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. |
format | Online Article Text |
id | pubmed-6847987 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Dove |
record_format | MEDLINE/PubMed |
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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