Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT01736592
Eligibility Criteria:
Inclusion Criteria:
Patients must meet ALL of the following criteria:
1. Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\])
2. Must have been enrolled in protocol TDU13583 (SG1/001/10)
3. Must have received a subretinal injection of SAR422459
4. Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit.
Exclusion Criteria:
The following would exclude Patients from participation in the study:
1\. Did not receive SAR422459 as part of the TDU13583 protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT01736592
Study Brief:
Protocol Section:
NCT01736592