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Clinical Trials in the USA / NCT01736592
Active, not recruiting Phase 2

Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration

NCT01736592 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2012-12-14
Last updated
2026-08-26

Condition(s) studied

Stargardt's Disease

Investigational drug(s) / intervention(s)

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)

FacilityCityRegionStatus
Oregon Health and Science University Site Number : 840001 Portland Oregon
Investigational Site Number : 250001 Paris France

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Official registry record

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.

View NCT01736592 on ClinicalTrials.gov ↗ ← All trials in the USA