Age-Related Macular Degeneration Clinical Trial
Official title:
Pharmacogenomic Study on Anti-VEGF Medicine in Treatment of Macular Neovascular Diseases
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Signed informed consent 2. 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 3. Patients plan to receive intravitreal injection of conbercept; 4. Patients should be resident in this region or who plans a long-term follow- up in the clinical center. Exclusion Criteria: 1. Participate in other intervention therapy at the same time 2. Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment . |
Country | Name | City | State |
---|---|---|---|
China | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai Shi | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xun Xu | Fourth Military Medical University, Peking University, Tianjin Medical University, Zhongshan Ophthalmic Center, Sun Yet-san University |
China,
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. Review. Erratum in: Eye (Lond). 2015 Oct;29(10):1397-8. Kelly, S [corrected to Kelly, S P]. — View Citation
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. — View Citation
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. — View Citation
Wong CW, Yanagi Y, Lee WK, Ogura Y, Yeo I, Wong TY, Cheung CM. Age-related macular degeneration and polypoidal choroidal vasculopathy in Asians. Prog Retin Eye Res. 2016 Jul;53:107-39. doi: 10.1016/j.preteyeres.2016.04.002. Epub 2016 Apr 14. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The off-label use of conbercept in real world. | Calculate the number of cases and percentage of off-label use(%)in real world. | Feb. 2017—Dec.2018 | |
Secondary | The application of off-label use on targeted diseases | Record the name of diseases when off-label use is applied. | Feb. 2017—Dec.2018 | |
Secondary | The number and percentage(%)of each target diseases in off-label use. | Calculate the the number and percentage(%)of each target diseases in off-label use respectively. | Feb. 2017—Dec.2018 | |
Secondary | The improvement of retinal edema after using conbercept | The improvement of retinal edema after using conbercept and compare the difference between central foveal retinal thickness (CRT in µm) and the baseline after 1 month, 3 months, 6 months, and 12 months. | Feb. 2017—Dec.2018 | |
Secondary | The different therapeutic regimens | The different therapeutic regimens when conbercept is applied on different diseases in real world, including number of treatments, frequency of injection(times per year), interval time(months). | Feb. 2017—Dec.2018 | |
Secondary | Dropout rate of the study. | Calculate the dropout rate(%) of each follow-up time and during the whole follow-up. | Feb. 2017—Dec.2018 | |
Secondary | Predict patients' response to conbercept on treating macular neovascular diseases by analyzing macular leakage area | After 3 months treatment, compare the macular leakage area (mm2) to baseline in Fluorescein Fundus Angiography (FFA) on patients who response to conbercept treatment and patients with no response, to further analyze the potential relationship with the response / non-response. | Feb. 2017—Dec.2018 | |
Secondary | Predict patients' response to conbercept on treating macular neovascular diseases by analyzing CNV area | After 3 months treatment, compare the CNV area (mm2) to baseline in FFA on patients who response to conbercept treatment and patients with no response, to further analyze the potential relationship with the response / non-response. | Feb. 2017—Dec.2018 |
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