Pharmacogenomic Study on Anti-VEGF Medicine in Treatment of Macular Neovascular Diseases

Summary

Macular neovascular diseases including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), pathological myopia (PM) and etc. can cause severe vision loss. It has become the focus of World Health Organization's blindness- prevention cause. A new anti-VEGF drug conbercept has been approved and showed good efficacy and safety in clinical trials. But the exact therapeutic regimen and the efficacy in the real world still needs to be further studied, the reasons are as follows:

1. The efficacy and safety data of conbercept are collected from rigorous random controlled trials (RCT) , it can not fully reflect the clinical application of conbercept in the real world . Therefore, the knowledge of the therapeutic regimen, safety and efficacy of conbercept is still limited.
2. Conbercept has been approved for wet-AMD only, but in clinical practice, some doctors applied other "off-label use" of conbercept. These "off-label use" has become a common phenomenon all over the world for the instruction book of drugs usually lag behind scientific researches. There is no specific law or regulatory document of drug off-label use in China until now.
3. 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. So, how to accurately find out those patients who have good response, how to develop individualized therapeutic regimen, and the response of patients in the real world need to be urgently investigated in the aspect of pharmacogenomics, and pharmacometabolomics.

Therefore, the investigators plan to carry out real-world researches of conbercept on treating macular neovascular diseases has significance and urgency.

The investigators intended to conduct a nationwide, non-intrusive, prospective, observational, and multicenter registration study to investigate the efficacy of conbercept in the real-world. And this study will explore the pharmacogenomics and pharmacometabolomics of conbercept, relationships of phenotype and the effectiveness of the drug, optimize the therapeutic regimen, then reduce the financial burden of patients and save the limited medical resources to achieve the purpose of accurate treatment.

For three unanswered questions raised in the background, the researchers carried out the following purposes:

1. Investigate the safety and efficacy of conbercept in treating neovascular macular disease in the real world.
2. Find out whether the "off-label use" of conbercept on PCV and PM have good efficacy.
3. Explore the pharmacogenomics and pharmacometabolomics of conbercept through large-sample registration study.

Conditions

• Age-Related Macular Degeneration
• Polypoidal Choroidal Vasculopathy
• Pathological Myopia
• Conbercept
• Pharmacogenomic

Interventions

DRUG

Intravitreal injection of conbercept

We observe and collect patients with macular neovascular diseases who had intravitreal injections of conbercept. We do not interfere patients' treatment plan.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University

  collaborator OTHER

• Peking University

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Tianjin Medical University

  collaborator OTHER

• Xun Xu

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-28

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• China