NCT01736592

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

An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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

Detailed description

Patients will be followed for 15 years after completion/early termination from the previous TDU13583 study (NCT01367444). As the initial TDU13583 study is terminated - recruitment to this LTS13588 study is over with 27 patients enrolled.

Conditions

• Stargardt's Disease

Interventions

Type	Name	Description
DRUG	Long term follow up in all patients who received SAR422459 in previous study TDU13583	Blood draw for the laboratory assessment

Timeline

• Start date: 2012-12-14
• Primary completion: 2033-08-29
• Completion: 2033-08-29
• First posted: 2012-11-29
• Last updated: 2025-06-12

Locations

2 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study