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

Sanofi

Status and phase: Active, not recruiting; Phase 2

Conditions: Stargardt's Disease

Treatments: Drug: Long term follow up in all patients who received SAR422459 in previous study TDU13583

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736592

LTS13588

2024-513501-31 (Registry Identifier)

SG1/002/11

2012-001990-95 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Long Term Follow up

Other group

Description:

Long term follow up in all patients who received SAR422459 in previous study TDU13583

Treatment:

Drug: Long term follow up in all patients who received SAR422459 in previous study TDU13583