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

Jin Jing, Shen Yinchen, Chen Xia, Wang Jing, Chen Chong, Xu Xun, Huang Hengye, Liu Kun, Jin Jing, Shen Yinchen, Chen Xia, Wang Jing, Chen Chong, Xu Xun, Huang Hengye, Liu Kun

Abstract

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.

Keywords: Anti-VEGF; Conbercept; Macular neovascular diseases; Pharmacogenomic.

Conflict of interest statement

Ethics approval and consent to participate

This study protocol has been approved by the Institutional Review Board of Shanghai General hospital, Shanghai Jiao Tong University School of Medicine(2016KY-115, 2017KY-115-2). The ethics approval by institutional Review Board of Shanghai General hospital, Shanghai Jiao Tong University School of Medicine is accepted by all other ophthalmic centers. And participation is voluntary and informed consent will be obtained before procedures.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of recruitment and observation procedures of this study. 1 m, 3 m,6 m, and 12 m means 1 month, 3 months, 6 months, and 12 months after Conbercept treatment

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Source: PubMed

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