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

Hoffmann-La Roche1,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Diabetic Macular Edema Neovascular Age-related Macular Degeneration Retinal Vein Occlusion

Interventions

Faricimab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (41)

Joint Shantou International Eye Center

Shantou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Henan UN of Science and Technology

Luoyang, Henan, China

RECRUITING

Taihe Hospital of Shiyan

Shiyan, Hubei, China

RECRUITING

Xuzhou No.1 Peoples Hospital

Xuzhou, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Month 12

Secondary Outcomes

Visual Acuity Over Time

Time frame: Baseline, Months 3, 6, 9, 12, 18, and 24

Change in Visual Acuity from Baseline Over Time

Time frame: Baseline, Months 3, 6, 9, 18, and 24

Central Subfield Thickness Over Time

Time frame: Baseline, Months 3, 6, 9, 12, 18, and 24

Change in Central Subfield Thickness from Baseline Over Time

Time frame: Baseline, Months 3, 6, 9, 12, 18, and 24

Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)

Time frame: From Baseline to Month 24

Number of Treatments per Year

Time frame: Months 12 and 24

Percentage of Eyes with Treatment Switch by Reason for Switch Over Time

Time frame: 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

Time frame: Months 3, 6, 9, 12, 18, and 24

Total Number of Visits per Year

Time frame: Months 12 and 24

Number of Visits With or Without Treatment per Year

Time frame: Months 12 and 24

Time Interval Between Treatments per Year

Time frame: Months 12 and 24

Percentage of Eyes Treated with Ocular Concomitant Medications or Therapy by Type and Frequency During the Study

Time frame: 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

Time frame: Months 12, 18, and 24

Percentage of Eyes According to the Last Treatment Interval at Months 3, 6, 12, 18, and 24

Time frame: Months 3, 6, 12, 18, and 24

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

Overview

Conditions

Interventions

Eligibility

Locations (41)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts