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

NCT03128463 | Unknown DMC

• 1 other identifier: 2016YFC0904800
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Age-Related Macular Degeneration; Polypoidal Choroidal Vasculopathy; Pathological Myopia; Conbercept

Outcome Measures

Primary Outcomes (1)

• visual improvement after intravitreal injection of conbercept

  The efficacy was graded as significantly effective (visual improvement ≥15 letters in EDTRS )，effective (visual improvement ≥5 letters and \<15 letters in EDTRS），invalid（visual improvement \<5 letters and visual reduction\<5 letters in EDTRS， deterioration （visual reduction≥5 letters in EDTRS. The number and ratio of the above-mentioned grade are to be analyzed.

  Feb. 2017-Dec.2018

Secondary Outcomes (8)

• The off-label use of conbercept in real world.

  Feb. 2017-Dec.2018

• The application of off-label use on targeted diseases

  Feb. 2017-Dec.2018

• The number and percentage（%）of each target diseases in off-label use.

  Feb. 2017-Dec.2018

• The improvement of retinal edema after using conbercept

  Feb. 2017-Dec.2018

• The different therapeutic regimens

  Feb. 2017-Dec.2018

Study Arms (4)

significantly effective group

visual improvement ≥15 letters in Early Treatment Diabetic Retinopathy Study (EDTRS) table after intravitreal injection of conbercept

Drug: Intravitreal injection of conbercept

effective group

visual improvement ≥5 letters and \<15 letters in EDTRS table after intravitreal injection of conbercept

Drug: Intravitreal injection of conbercept

invalid group

visual improvement \<5 letters and visual reduction\<5 letters in EDTRS table after intravitreal injection of Combercept

Drug: Intravitreal injection of conbercept

deterioration group

visual reduction≥5 letters in EDTRS table after intravitreal injection of conbercept

Drug: Intravitreal injection of conbercept

Interventions

Intravitreal injection of conbercept DRUG

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

deterioration group; effective group; invalid group; significantly effective group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators plan to observe and collect patients with macular neovascular diseases and are going to receive conbercept treatment. The investigators do not interfere patients's treatment plan.

You may qualify if:

• Signed informed consent
• Patients were diagnosed with macular neovascular disease (wet age- related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV)and choroidal neovascularization secondary to pathological myopia (PM) ), no gender requirement, age ≥ 18years
• Patients plan to receive intravitreal injection of conbercept;
• Patients should be resident in this region or who plans a long-term follow- up in the clinical center.

You may not qualify if:

• Participate in other intervention therapy at the same time
• Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment .

Sponsors & Collaborators

• Xun Xu: lead
• Zhongshan Ophthalmic Center, Sun Yat-sen University: collaborator
• Peking University: collaborator
• Air Force Military Medical University, China: collaborator
• Tianjin Medical University: collaborator

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai Shi, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (6)

• Wong CW, Yanagi Y, Lee WK, Ogura Y, Yeo I, Wong TY, Cheung CMG. Age-related macular degeneration and polypoidal choroidal vasculopathy in Asians. Prog Retin Eye Res. 2016 Jul;53:107-139. doi: 10.1016/j.preteyeres.2016.04.002. Epub 2016 Apr 14.

  PMID: 27094371 BACKGROUND

• CATT Research Group; Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.

  PMID: 21526923 BACKGROUND

• Li X, Xu G, Wang Y, Xu X, Liu X, Tang S, Zhang F, Zhang J, Tang L, Wu Q, Luo D, Ke X; AURORA Study Group. Safety and efficacy of conbercept in neovascular age-related macular degeneration: results from a 12-month randomized phase 2 study: AURORA study. Ophthalmology. 2014 Sep;121(9):1740-7. doi: 10.1016/j.ophtha.2014.03.026. Epub 2014 May 1.

  PMID: 24793528 BACKGROUND

• Amoaku WM, Chakravarthy U, Gale R, Gavin M, Ghanchi F, Gibson J, Harding S, Johnston RL, Kelly SP, Lotery A, Mahmood S, Menon G, Sivaprasad S, Talks J, Tufail A, Yang Y. Defining response to anti-VEGF therapies in neovascular AMD. Eye (Lond). 2015 Jun;29(6):721-31. doi: 10.1038/eye.2015.48. Epub 2015 Apr 17.

  PMID: 25882328 BACKGROUND

• Qu Y, Liu Y, Fang J, Chen C, Cheng L, Xu X, Jin J, Chen X, Niu T, Wang H, Xing X, Shi X, Shen Y, Liu K. Dysregulated serum lipid profiles in neovascular age-related macular degeneration revealed by UPLC-MS/MS lipidomics. Lipids Health Dis. 2025 Sep 29;24(1):302. doi: 10.1186/s12944-025-02735-y.

  PMID: 41023746 DERIVED

• Jing J, Yinchen S, Xia C, Jing W, Chong C, Xun X, Hengye H, Kun L. Pharmacogenomic study on anti-VEGF medicine in treatment of macular Neovascular diseases: a study protocol for a prospective observational study. BMC Ophthalmol. 2018 Jul 24;18(1):181. doi: 10.1186/s12886-018-0812-4.

  PMID: 30041608 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Polypoidal Choroidal Vasculopathy; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myopia; Refractive Errors

Central Study Contacts

Xun Xu, MS，MD.

CONTACT

+86-13386259538; drxuxun@sjtu.edu.cn

Jinye Wu, MD

CONTACT

+86-13651798760; wujinye0603@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: April 25, 2017
• Study Start: February 28, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)