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Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study

BACKGROUND: Macular neovascular diseases can cause severe vision loss. A newly approved anti—VEGF drug Conbercept has shown good efficacy and safety in rigorous random controlled trials (RCT), however, it cannot fully reflect the clinical application of Conbercept in real world clinical practice. Mo...

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Autores principales: Jing, Jin, Yinchen, Shen, Xia, Chen, Jing, Wang, Chong, Chen, Xun, Xu, Hengye, Huang, Kun, Liu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057085/
https://www.ncbi.nlm.nih.gov/pubmed/30041608
http://dx.doi.org/10.1186/s12886-018-0812-4
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author Jing, Jin
Yinchen, Shen
Xia, Chen
Jing, Wang
Chong, Chen
Xun, Xu
Hengye, Huang
Kun, Liu
author_facet Jing, Jin
Yinchen, Shen
Xia, Chen
Jing, Wang
Chong, Chen
Xun, Xu
Hengye, Huang
Kun, Liu
author_sort Jing, Jin
collection PubMed
description BACKGROUND: Macular neovascular diseases can cause severe vision loss. A newly approved anti—VEGF drug Conbercept has shown good efficacy and safety in rigorous random controlled trials (RCT), however, it cannot fully reflect the clinical application of Conbercept in real world clinical practice. Moreover, anti-VEGF drugs are expensive and often require multiple treatments, and some patients have poor or even no response to the drugs,this resulted enormous waste of medical resources. Therefore, how to find out those patients who have good response, and how to develop individualized therapeutic regimen in real world need to be urgently investigated in the aspect of pharmacogenomics and pharmacometabolomics. METHODS: This study is a multicenter, prospective, observational study of Conbecept treating macular neovascular diseases in China. Patients suffered from age-related macular degeneration, polypoidal choroidal vasculopathy, and pathological myopia who already planned to receive Conbercept treatment will be recruited. We aimed to enroll more than 5000 patients from 43 ophthalmic centers in China. Patients’ clinical data and blood samples will be collected during the one-year follow-up period. Finally, the safety and efficacy of Conbercept, and the potential predictors of patients’ response to Conbercept will be investigated by pharmacogenomics and pharmacometabolomics analysis. DISCUSSION: This study will provide important data of Conbercept in treating macular neovascular diseases in real world. Besides, finding the predictor of patients’ response will help doctor make more precise individualized therapeutic regimens. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03128463. Registered on 9 March 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12886-018-0812-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-60570852018-07-30 Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study Jing, Jin Yinchen, Shen Xia, Chen Jing, Wang Chong, Chen Xun, Xu Hengye, Huang Kun, Liu BMC Ophthalmol Study Protocol BACKGROUND: Macular neovascular diseases can cause severe vision loss. A newly approved anti—VEGF drug Conbercept has shown good efficacy and safety in rigorous random controlled trials (RCT), however, it cannot fully reflect the clinical application of Conbercept in real world clinical practice. Moreover, anti-VEGF drugs are expensive and often require multiple treatments, and some patients have poor or even no response to the drugs,this resulted enormous waste of medical resources. Therefore, how to find out those patients who have good response, and how to develop individualized therapeutic regimen in real world need to be urgently investigated in the aspect of pharmacogenomics and pharmacometabolomics. METHODS: This study is a multicenter, prospective, observational study of Conbecept treating macular neovascular diseases in China. Patients suffered from age-related macular degeneration, polypoidal choroidal vasculopathy, and pathological myopia who already planned to receive Conbercept treatment will be recruited. We aimed to enroll more than 5000 patients from 43 ophthalmic centers in China. Patients’ clinical data and blood samples will be collected during the one-year follow-up period. Finally, the safety and efficacy of Conbercept, and the potential predictors of patients’ response to Conbercept will be investigated by pharmacogenomics and pharmacometabolomics analysis. DISCUSSION: This study will provide important data of Conbercept in treating macular neovascular diseases in real world. Besides, finding the predictor of patients’ response will help doctor make more precise individualized therapeutic regimens. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03128463. Registered on 9 March 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12886-018-0812-4) contains supplementary material, which is available to authorized users. BioMed Central 2018-07-24 /pmc/articles/PMC6057085/ /pubmed/30041608 http://dx.doi.org/10.1186/s12886-018-0812-4 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Jing, Jin
Yinchen, Shen
Xia, Chen
Jing, Wang
Chong, Chen
Xun, Xu
Hengye, Huang
Kun, Liu
Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study
title Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study
title_full Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study
title_fullStr Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study
title_full_unstemmed Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study
title_short Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study
title_sort pharmacogenomic study on anti-vegf medicine in treatment of macular neovascular diseases: a study protocol for a prospective observational study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057085/
https://www.ncbi.nlm.nih.gov/pubmed/30041608
http://dx.doi.org/10.1186/s12886-018-0812-4
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