Macular degeneration Eye Diseases Macular degeneration
Conditions
Interventions
Participants will be placed in a single treatment group:
Participants will receive faricimab 6 mg injections into the study eye at a variable interval depending on the condition of their eye. Frequenc
Sponsors
F. Hoffman-la Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previous enrollment in and completion of any faricimab parent study without study or study drug discontinuation. 2. Enrolled in the mainland of China 3. Signed Informed Consent Form 4. Ability and willingness to comply with the study protocol, in the investigator's judgment
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final ITV injection of faricimab 2. Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Eye condition measured using BCVA, pre-treatment IOP, slit-lamp examination, and Indirect ophthalmoscopy measured at baseline (Day 1) and each visit which is in the range of 21 days to 4 months 2. Effect of drug measured using finger-counting test and IOP (post-study treatment) are measured after each administration. As the study drug administration has no mandatory timepoint and is decided by the clinical judgment of the investigator, these assessments have no specified timepoint 3. Other eye tests, SD-OCT, CFP, and FFA are also measured according to the investigator's discretion, they have no specified timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
China
Contacts
Public ContactClinical Trials
Outcome results
None listed