Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
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ClinicalTrials.gov Identifier: NCT01736592 |
Recruitment Status
:
Recruiting
First Posted
: November 29, 2012
Last Update Posted
: January 23, 2018
|
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stargardt's Disease | Drug: SAR422459 administered in previous study TDU13583 | Phase 1 Phase 2 |
Patients will be followed for 15 years after completion/early termination from the previous TDU13583 study (NCT01367444).
No treatment with study drug is administered in this LTS13588 study. Patients are only followed after treatment with SAR422459 in previous TDU13583 study.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 46 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration |
Actual Study Start Date : | December 14, 2012 |
Estimated Primary Completion Date : | November 27, 2034 |
Estimated Study Completion Date : | November 27, 2034 |

Arm | Intervention/treatment |
---|---|
Long Term Follow up
Long term follow up in all patients who received SAR422459 in previous study TDU13583
|
Drug: SAR422459 administered in previous study TDU13583
No study drug given in LTS13588
|
- The incidence of Adverse Events [ Time Frame: 15 years ]The number of patients with treatment emergent adverse events
- Delay in retinal degeneration [ Time Frame: 15 years ]The change from baseline function relative to the contralateral eye utilising retinal analytical techniques

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet ALL of the following criteria:
- Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA])
- Must have been enrolled in protocol TDU13583 (SG1/001/10)
- Must have received a subretinal injection of SAR422459
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736592
Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
United States, Oregon | |
Investigational Site Number 840001 | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
France | |
Investigational Site Number 250001 | Recruiting |
Paris, France, 75012 |
Principal Investigator: | David Wilson, MD | Oregon Health and Science University | |
Principal Investigator: | José-Alain Sahel, MD | Centre National d'Ophtalmologie des Quinze-Vingts |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01736592 History of Changes |
Other Study ID Numbers: |
LTS13588 SG1/002/11 |
First Posted: | November 29, 2012 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Additional relevant MeSH terms:
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |