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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06439576
Other study ID # ML45401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 9, 2024
Est. completion date November 30, 2027

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact Reference Study ID Number: ML45401 https://forpatients.roche.com
Phone 888-662-6728 (U.S. Only)
Email global-roche-genentech-trials@gene.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date November 30, 2027
Est. primary completion date November 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Shanghai First People's Hospital Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Hoffmann-La Roche Shanghai Roche Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

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