Clinical trial NCT06439576: Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Macular Edema
Neovascular Age-related Macular Degeneration
Retinal Vein Occlusion
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Roche Pharmaceutical Co., Ltd
First posted: 2024-06-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Acuity from Baseline at Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Visual Acuity Over Time
timeFrame: Baseline, Months 3, 6, 9, 12, 18, and 24
measure: Change in Visual Acuity from Baseline Over Time
timeFrame: Baseline, Months 3, 6, 9, 18, and 24
measure: Central Subfield Thickness Over Time
timeFrame: Baseline, Months 3, 6, 9, 12, 18, and 24
measure: Change in Central Subfield Thickness from Baseline Over Time
timeFrame: Baseline, Months 3, 6, 9, 12, 18, and 24
measure: Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)
timeFrame: From Baseline to Month 24
measure: Number of Treatments per Year
timeFrame: Months 12 and 24
measure: Percentage of Eyes with Treatment Switch by Reason for Switch Over Time
timeFrame: Months 3, 6, 9, 12, 18, and 24
measure: Percentage of Eyes with Treatment Regimen Switch (Fixed, Treat-and-Extend, As Needed, or Other) by Reason for Switch Over Time
timeFrame: Months 3, 6, 9, 12, 18, and 24
measure: Total Number of Visits per Year
timeFrame: Months 12 and 24
measure: Number of Visits With or Without Treatment per Year
timeFrame: Months 12 and 24
measure: Time Interval Between Treatments per Year
timeFrame: Months 12 and 24
measure: Percentage of Eyes Treated with Ocular Concomitant Medications or Therapy by Type and Frequency During the Study
timeFrame: From Baseline until end of study (up to 3.5 years)
measure: Number of Participants Lost to Follow-Up More Than 6 Months at Months 12, 18, and 24
timeFrame: Months 12, 18, and 24
measure: Percentage of Eyes According to the Last Treatment Interval at Months 3, 6, 12, 18, and 24
timeFrame: Months 3, 6, 12, 18, and 24
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Eye Hospital of Shandong First Medical University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Weifang
country: China
facility: Affiliated Hospital of Shandong Second Medical University
city: Wuhan City
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
city: Xingtai
country: China
facility: Hebei Eye Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: