Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusion
Conditions
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.
Interventions
DRUGFaricimab
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.
Sponsors
Hoffmann-La Roche
Shanghai Roche Pharmaceutical Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Visual Acuity Over Time | Baseline, Months 3, 6, 9, 12, 18, and 24 |
| Change in Visual Acuity from Baseline Over Time | Baseline, Months 3, 6, 9, 18, and 24 |
| Central Subfield Thickness 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 |
| Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) | From Baseline to Month 24 |
| Number of Treatments per Year | Months 12 and 24 |
| Percentage of Eyes with Treatment Switch by Reason for Switch Over Time | 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 | Months 3, 6, 9, 12, 18, and 24 |
| Total Number of Visits per Year | Months 12 and 24 |
| Number of Visits With or Without Treatment per Year | Months 12 and 24 |
| Time Interval Between Treatments per Year | Months 12 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) |
| Number of Participants Lost to Follow-Up More Than 6 Months at Months 12, 18, and 24 | Months 12, 18, and 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 |
Countries
China
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed