Long term follow up in all patients who received SAR422459 in previous study TDU13583
Long term follow up in all patients who received SAR422459 in previous study TDU13583: Blood draw for the laboratory assessment
Study summary
Primary Objective:
To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration.
Secondary Objective:
To assess:
* Safety
* Biological activity
Eligibility
Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The incidence of Adverse Events — 15 years The number and percentage of patients with treatment emergent adverse events
Trial sites (2)
Facility
City
Region
Status
Oregon Health and Science University Site Number : 840001
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.