Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 33 for:    myopic macular degeneration

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03128463
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Peking University
Fourth Military Medical University
Tianjin Medical University
Information provided by (Responsible Party):
Xun Xu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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. 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.

Condition or disease Intervention/treatment
Age-Related Macular Degeneration Polypoidal Choroidal Vasculopathy Pathological Myopia Conbercept Pharmacogenomic Drug: Intravitreal injection of conbercept

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomic Study on Anti-VEGF Medicine in Treatment of Macular Neovascular Diseases
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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

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

invalid group
visual improvement <5 letters and visual reduction<5 letters in EDTRS table after intravitreal injection of Combercept
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.

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




Primary Outcome Measures :
  1. visual improvement after intravitreal injection of conbercept [ Time Frame: Feb. 2017—Dec.2018 ]
    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.


Secondary Outcome Measures :
  1. The off-label use of conbercept in real world. [ Time Frame: Feb. 2017—Dec.2018 ]
    Calculate the number of cases and percentage of off-label use(%)in real world.

  2. The application of off-label use on targeted diseases [ Time Frame: Feb. 2017—Dec.2018 ]
    Record the name of diseases when off-label use is applied.

  3. The number and percentage(%)of each target diseases in off-label use. [ Time Frame: Feb. 2017—Dec.2018 ]
    Calculate the the number and percentage(%)of each target diseases in off-label use respectively.

  4. The improvement of retinal edema after using conbercept [ Time Frame: Feb. 2017—Dec.2018 ]
    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.

  5. The different therapeutic regimens [ Time Frame: Feb. 2017—Dec.2018 ]
    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).

  6. Dropout rate of the study. [ Time Frame: Feb. 2017—Dec.2018 ]
    Calculate the dropout rate(%) of each follow-up time and during the whole follow-up.

  7. Predict patients' response to conbercept on treating macular neovascular diseases by analyzing macular leakage area [ Time Frame: Feb. 2017—Dec.2018 ]
    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.

  8. Predict patients' response to conbercept on treating macular neovascular diseases by analyzing CNV area [ Time Frame: Feb. 2017—Dec.2018 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128463


Contacts
Layout table for location contacts
Contact: Xun Xu, MS,MD. +86-13386259538 drxuxun@sjtu.edu.cn
Contact: Jinye Wu, MD +86-13651798760 wujinye0603@126.com

Locations
Layout table for location information
China, Shanghai
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai Shi, Shanghai, China, 200080
Contact: Xun Xu, MS, MD.    +86-13386259538    drxuxun@sjtu.edu.cn   
Contact: Jinye Wu, MD    +86-13651798760    wujinye0603@126.com   
Sponsors and Collaborators
Xun Xu
Zhongshan Ophthalmic Center, Sun Yat-sen University
Peking University
Fourth Military Medical University
Tianjin Medical University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Xun Xu, Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03128463     History of Changes
Other Study ID Numbers: 2016YFC0904800
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xun Xu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Age-Related Macular Degeneration
Polypoidal Choroidal Vasculopathy
Pathological Myopia
Conbercept

Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Myopia
Myopia, Degenerative
Retinal Degeneration
Vascular Diseases
Retinal Diseases
Eye Diseases
Refractive Errors
Cardiovascular Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors