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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439576
• Other study ID #: ML45401
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-related Macular Degeneration
• Papilledema
• Retinal Vein Occlusion
• Wet Macular Degeneration

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