A study to evaluate the long-term safety and tolerability of faricimab administered in patients previously enrolled in Roche-sponsored studies
Phase 3
- Conditions
- Macular degenerationEye Diseases
- Registration Number
- ISRCTN14123846
- Lead Sponsor
- F. Hoffman-la Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 350
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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<br>3. Other eye tests, SD-OCT, CFP, and FFA are also measured according to the investigator's discretion, they have no specified timepoint
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures