Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration

Stargardt's Disease Clinical Trial

Official title:
A Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients With Stargardt's Macular Degeneration

Status Terminated

Clinical Trial Summary

Primary Objective: To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardt's Macular Degeneration (SMD). Secondary Objective: To evaluate for possible biological activity of SAR422459.

Clinical Trial Description

The total duration per participant was up to 52 weeks, which included 4 week screening period and 48 weeks study period. At the end of the study, the participants were invited to enter in an open-label safety study (LTS13588-NCT01736592) for long-term follow-up visits including ophthalmological examinations and recording of adverse events (AEs) for up to 15 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01367444
Study type	Interventional
Source	Sanofi
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	June 8, 2011
Completion date	August 16, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02617966` - Rod and Cone Mediated Function in Retinal Disease
Completed	`NCT01790958` - Microcurrent Stimulation to Treat Macular Degeneration	N/A
Active, not recruiting	`NCT01736592` - Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration	Phase 1/Phase 2
Completed	`NCT02903576` - Stem Cell Therapy for Outer Retinal Degenerations	Phase 1/Phase 2