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| Name | Class |
|---|---|
| Shanghai Roche Pharmaceutical Co., Ltd | UNKNOWN |
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The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving treatment with faricimab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Patients with nAMD |
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| Cohort 2: Patients with DME |
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| Cohort 3: Patients with RVO |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab | Drug | The dosing and treatment duration of the studied medicinal product is at the discretion of the physician in accordance with clinical practice and labeling in China. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity from Baseline at Month 12 | Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score. | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity Over Time | Baseline, Months 3, 6, 9, 12, 18, and 24 | |
| Change in Visual Acuity from Baseline Over Time | Baseline, Months 3, 6, 9, 18, and 24 | |
| Central Subfield Thickness Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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The study will recruit patients who are naïve to anti-VEGF therapy in the study eye and those who have previously been treated with anti-VEGF therapy in the study eye. Study participation of patients previously treated with other anti-VEGF agents will be capped at a maximum of 40% of each indication enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Shantou International Eye Center | Shantou | Guangdong | 515051 | China | ||
| The First Affiliated Hospital of Henan UN of Science and Technology |
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|
| Baseline, Months 3, 6, 9, 12, 18, and 24 |
| Change in Central Subfield Thickness from Baseline Over Time | Baseline, Months 3, 6, 9, 12, 18, and 24 |
| Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) | From Baseline to Month 24 |
| Number of Treatments per Year | Months 12 and 24 |
| Percentage of Eyes with Treatment Switch by Reason for Switch Over Time | Months 3, 6, 9, 12, 18, and 24 |
| Percentage of Eyes with Treatment Regimen Switch (Fixed, Treat-and-Extend, As Needed, or Other) by Reason for Switch Over Time | Months 3, 6, 9, 12, 18, and 24 |
| Total Number of Visits per Year | Months 12 and 24 |
| Number of Visits With or Without Treatment per Year | Months 12 and 24 |
| Time Interval Between Treatments per Year | Months 12 and 24 |
| Percentage of Eyes Treated with Ocular Concomitant Medications or Therapy by Type and Frequency During the Study | From Baseline until end of study (up to 3.5 years) |
| Number of Participants Lost to Follow-Up More Than 6 Months at Months 12, 18, and 24 | Months 12, 18, and 24 |
| Percentage of Eyes According to the Last Treatment Interval at Months 3, 6, 12, 18, and 24 | Months 3, 6, 12, 18, and 24 |
| Luoyang |
| Henan |
| 471000 |
| China |
| Taihe Hospital of Shiyan | Shiyan | Hubei | 442000 | China |
| Xuzhou No.1 Peoples Hospital | Xuzhou | Jiangsu | 221002 | China |
| Fushun Eye Hospital | Fushun | Liaoning | 110114 | China |
| Panjin Central Hospital | Panjin | Liaoning | 124010 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Affiliated Hospital of Shandong Second Medical University | Weifang | Shandong | 261031 | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| The First People's Hospital of Chengdu | Chengdu | Sichuan | 610016 | China |
| The First People's Hospital of Kashgar | Kashgar | Xinjiang Uygur | 844000 | China |
| The First People's Hospital of Yunnan Province | Kunming | Yun'nan | 650032 | China |
| Jinhua municipal central hospital | Jinhua | Zhejiang | 321083 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| Sichuan Provincial People's Hospital | Chengdu | 610072 | China |
| People's Hospital of Dingzhou | Dingzhou | 73000 | China |
| Dongyang People's Hospital | Dongyang | 322100 | China |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | 510060 | China |
| Guizhou Provincial People's Hospital | Guiyang | 550002 | China |
| Eye Hospital of Shandong First Medical University | Jinan | 250021 | China |
| The First Affiliated Hospital of Lanzhou University | Lanzhou | 730000 | China |
| The Affiliated Hospital of Southwest Medical University, Zhongshan Campus | Luzhou | China |
| Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing | 210029 | China |
| The People?s Hospital of Guangxi Zhuang Autonomous Region | Nanning | 530021 | China |
| Qingdao Eye Hospital of Shandong First Medical University | Qingdao | 265299 | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | 200025 | China |
| Shanghai Tenth People's Hospital | Shanghai | 200072 | China |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200092 | China |
| Shanghai Zhoupu Hospital | Shanghai | China |
| Shenyang Fourth People's Hospital | Shenyang | 110031 | China |
| Shenzhen Eye Hospital | Shenzhen | 518040 | China |
| Hebei People's Hospital | Shijiazhuang | 050071 | China |
| Shanxi Bethune Hospital | Taiyuan | 030032 | China |
| Tianjin Eye Hospital | Tianjin | 300050 | China |
| Eye Hospital, Wenzhou Medical University | Wenzhou | 325027 | China |
| Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology | Wuhan | 430022 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430030 | China |
| Xiamen Eye Center Of Xiamen University | Xiamen | 361000 | China |
| Hebei Eye Hospital | Xingtai | China |
| Henan Provincial Eye Hosptial | Zhengzhou | 450003 | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | 563000 | China |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000723200 | faricimab |
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