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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:6 - Any
Updated:2/20/2019
Start Date:December 14, 2012
End Date:February 2035
Contact:Trial Transparency email recommended (Toll free number for US & Canada)
Email:Contact-Us@sanofi.com
Phone:800-633-1610

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Trial Summary
Trial Overview
Inclusion Criteria

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

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

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.

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.
We found this trial at
2
sites
Clinical Trial Facility in Paris
Paris, 75231
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Paris,
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Clinical Trial Facility in Portland Oregon
Portland, Oregon
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Portland, OR
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