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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The goal of this observational study is to explore the effectiveness of aflibercept 8 mg in treating both treatment-naive and previously treated patients with neovascular age-related macular degeneration (nAMD) in a real-world setting. The main questions it aims to answer are:
What are the short-term and long-term efficacy outcomes of aflibercept 8 mg in treatment-naive or previously treated nAMD patients? What are the safety characteristics and the treatment patterns of aflibercept 8 mg in these patient populations?
Participants will:
Receive aflibercept 8 mg as part of their clinical treatment for nAMD. Undergo assessments to evaluate both the efficacy and safety of the treatment over the short and long term.
Provide data on their visual acuity (BCVA) changes at multiple follow-up points (4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months).
Report any adverse events and treatment patterns during the study period. Have their central subfield thickness (CST) measured at specified intervals. This study will help inform clinical practices regarding the use of aflibercept in nAMD patients and contribute to understanding its effectiveness and safety in real-world settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naïve nAMD | 200 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up. |
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| pretreated nAMD | 100 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept 8mg | Drug | Aflibercept 8mg, following the manner of observational study, no intervention will be provided in the study. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and follows approved clinical guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of best corrected visual acuity (BCVA) from baseline to 12 months（BCVA will be examined under real-world conditions and converted into ETDRS letters. ） | Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months as evaluated in routine clinical practice | Baseline to Month 12 | |
| The change of central subfield thickness(CST) from baseline to 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months as evaluated in routine clinical practice |
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Inclusion Criteria:
Exclusion Criteria:
Participation in an investigational program with interventions outside of clinical routine practice
Contraindications as listed in the intravitreal aflibercept 8 mg local product information (Ocular or periocular infections, severe active intraocular inflammation, and known allergy to aflibercept or any of its excipients)
The fellow eye has received intravitreal anti-VEGF treatment other than aflibercept within 28 days prior to enrollment
Intraocular pressure (IOP) in the study eye > 25 mmHg
Additional exclusion criteria for naïve nAMD patients:
Additional exclusion criteria for pretreated nAMD patients:
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Patients will be enrolled in eye clinics or ophthalmology practices
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingwei Zhao | Contact | +86 13801057408 | dr_zhaomingwei@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Baseline to Month 12 |
| Number of aflibercept 8 mg injections in the study eye during the first 6 months and 12 months | Baseline to Month 12 |
| Number of visits regarding the study eye by type of visit during the 6 months and 12 months treatment period | Baseline to Month 12 |
| The proportion of study eyes for each treatment regimen (fixed regimen, treatment-extension regimen, as-needed regimen, or other regimens) from baseline to 6 months and 12 months. | Baseline to Month 12 |
| The proportion of study eyes for the distribution of the last treatment interval from baseline to 6 months and 12 months. | Baseline to Month 12 |
| The number of patients who experienced (serious) adverse events and (serious) drug-related adverse events from the baseline to 12 months thereafter. | Baseline to Month 12 |
| Percentage of eyes without IRF and/or SRF in the central macular area at 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months after the 8 mg injection of Aflibercept compared to before the injection. | Baseline to Month 12 |
| Percentage of eyes with regression/or improvement of PED at 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months after the 8 mg injection of Aflibercept compared to before the injection. | Baseline to Month 12 |
| Beijing CHAO-YANG Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
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| Beijing Haidian Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Peking University Third Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| The First Affiliated Hospital Of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | China |
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| Shenzhen Eye Hospital | Not yet recruiting | Shenzhen | Guangdong | China |
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| Affiliated Hospital Of Zunyi Medical University | Not yet recruiting | Zunyi | Guizhou | China |
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| The 2nd Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | China |
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| Nanyang Eye Hospital | Recruiting | Nanyang | Henan | China |
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| Tongji Hospital Tongji Medical College of HUST | Not yet recruiting | Wuhan | Hubei | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
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| The Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | China |
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| Dalian No.3 People's Hospital | Recruiting | Dalian | Liaoning | China |
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| The Fourth People's Hospital Of Shenyang | Not yet recruiting | Shenyang | Liaoning | China |
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| Xi'an People's Hospital | Not yet recruiting | Xi'an | Shaanxi | China |
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| Jinan Second People's Hospital | Not yet recruiting | Jinan | Shandong | China |
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| Qingdao Eye Hospital Of Shandong First Medical University | Not yet recruiting | Qingdao | Shandong | China |
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| Shanghai Tenth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| TONG REN Hospital, Shanghai Jiao Tong University School Of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | China |
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| Tianjin Medical University Eye Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| Ningbo Eye Hospital | Not yet recruiting | Ningbo | Zhejiang | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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