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

Recruiting

• Conditions: Retinal Vein Occlusion; Diabetic Macular Edema; Neovascular Age-related Macular Degeneration
• Interventions: Drug: Faricimab

• Registration Number: NCT06439576
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-09
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 3: Patients with RVO	Faricimab	-
Cohort 1: Patients with nAMD	Faricimab	-
Cohort 2: Patients with DME	Faricimab	-

Primary Outcome Measures

Name	Time	Method
Change in Visual Acuity from Baseline at Month 12	Baseline and Month 12	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

Secondary Outcome Measures

Name	Time	Method
Visual Acuity 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
Number of Treatments per Year	Months 12 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
Number of Visits With or Without Treatment per Year	Months 12 and 24
Change in Visual Acuity from Baseline Over Time	Baseline, Months 3, 6, 9, 18, and 24
Percentage of Eyes with Treatment Switch by Reason for Switch Over Time	Months 3, 6, 9, 12, 18, and 24
Time Interval Between Treatments per Year	Months 12 and 24
Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)	From Baseline to Month 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
Central Subfield Thickness Over Time	Baseline, Months 3, 6, 9, 12, 18, 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)
Total Number of Visits per Year	Months 12 and 24
Number of Participants Lost to Follow-Up More Than 6 Months at Months 12, 18, and 24	Months 12, 18, and 24

Trial Locations

Locations (6)

Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology; 🇨🇳 Wuhan, China

Qingdao Eye Hospital of Shandong First Medical University; 🇨🇳 Qingdao, China

Shanghai First People's Hospital; 🇨🇳 Shanghai, China

Affiliated Hospital of Shandong Second Medical University; 🇨🇳 Weifang, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan City, China

Hebei Eye Hospital; 🇨🇳 Xingtai, China