Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)

China Faricimab Real World Evidence: Evaluation of Faricimab Effectiveness, Safety and Treatment Pattern, in Diabetic Macular Edema, Retinal Vein Occlusion and Neovascular Age-Related Macular Degeneration: The Farseeing Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Macular Edema; Retinal Vein Occlusion; Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Faricimab

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Chengdu, China, 610072
    • Sichuan Provincial People's Hospital
  • Dingzhou, China, 73000
    • People's Hospital of Dingzhou
  • Dongyang, China, 322100
    • Dongyang People's Hospital
  • Guangzhou, China, 510060
    • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Guiyang, China, 550002
    • Guizhou Provincial People's Hospital
  • Jinan, China, 250021
    • Eye Hospital of Shandong First Medical University
  • Lanzhou, China, 730000
    • The First Affiliated Hospital of Lanzhou University
  • Luzhou, China
    • The Affiliated Hospital of Southwest Medical University, Zhongshan Campus
  • Nanjing, China, 210029
    • Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
  • Nanning, China, 530021
    • The People?s Hospital of Guangxi Zhuang Autonomous Region
  • Qingdao, China, 265299
    • Qingdao Eye Hospital of Shandong First Medical University
  • Shanghai, China, 200092
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai, China, 200072
    • Shanghai Tenth People's Hospital
  • Shanghai, China, 200025
    • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • Shanghai Zhoupu Hospital
  • Shenyang, China, 110031
    • Shenyang Fourth People's Hospital
  • Shenzhen, China, 518040
    • Shenzhen Eye Hospital
  • Shijiazhuang, China, 050071
    • Hebei People's Hospital
  • Taiyuan, China, 030032
    • Shanxi Bethune Hospital
  • Tianjin, China, 300050
    • Tianjin Eye Hospital
  • Wenzhou, China, 325027
    • Eye Hospital, Wenzhou Medical University
  • Wuhan, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Wuhan, China, 430022
    • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
  • Xiamen, China, 361000
    • Xiamen Eye Center of Xiamen University
  • Xingtai, China
    • Hebei Eye Hospital
  • Zhengzhou, China, 450003
    • Henan Provincial Eye Hosptial
  • Zunyi, China, 563000
    • Affiliated Hospital of Zunyi Medical University
  • Guangdong
    • Shantou, Guangdong, China, 515051
      • Joint Shantou International Eye Center
  • Henan
    • Luoyang, Henan, China, 471000
      • The First Affiliated Hospital of Henan UN of Science and Technology
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Taihe Hospital of Shiyan
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221002
      • Xuzhou No.1 Peoples Hospital
  • Liaoning
    • Fushun, Liaoning, China, 110114
      • Fushun Eye Hospital
    • Panjin, Liaoning, China, 124010
      • Panjin Central Hospital
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Shandong
    • Weifang, Shandong, China, 261031
      • Affiliated Hospital of Shandong Second Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Shanghai General Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610016
      • The First People's Hospital of Chengdu
  • Xinjiang Uygur
    • Kashgar, Xinjiang Uygur, China, 844000
      • The First People's Hospital of Kashgar
  • Yun'nan
    • Kunming, Yun'nan, China, 650032
      • The First People's Hospital of Yunnan Province
  • Zhejiang
    • Jinhua, Zhejiang, China, 321083
      • Jinhua Municipal Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Have signed the informed consent
2. Female and male Chinese patients, who had been diagnosed with nAMD, DME, or RVO by CFP, OCT, FFA, ICGA, or OCTA
3. ≥50 years old for patients with nAMD, ≥18 years old both for patients with DME and RVO, at the time of signing informed consent (or the first administration of faricimab, whichever occurs first)
4. Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation
5. Patients have received at least one faricimab treatment (the first dose) in the study eye

Exclusion Criteria:

1. Patients not receiving treatment for nAMD/DME/RVO with faricimab according to the standard of care and in line with the current summary of product characteristics (SPC) / labeling in China
2. Active ocular inflammation or suspected / active ocular infection in either eye
3. Received any other anti-VEGF treatment after faricimab
4. Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye
5. Any participation in any other clinical trials currently
6. Patients could not provide the clinical data (visual acuity and OCT images) within 2 weeks (14 days) before receiving the initial faricimab injection

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: Patients with nAMD	Drug: Faricimab; 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.; Other Names: VABYSMO®
Cohort 2: Patients with DME	Drug: Faricimab; 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.; Other Names: VABYSMO®
Cohort 3: Patients with RVO	Drug: Faricimab; 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.; Other Names: VABYSMO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Shanghai Roche Pharmaceutical Co., Ltd
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Embolism and Thrombosis; Retinal Diseases; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; faricimab
• Other Study ID Numbers: ML45401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No