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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-14

Study Completion Date

2033-08-29

Brief Summary

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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

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Detailed Description

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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

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Stargardt's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Long Term Follow up

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

Group Type OTHER

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

Intervention Type DRUG

Blood draw for the laboratory assessment

Interventions

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

Blood draw for the laboratory assessment

Intervention Type DRUG

Eligibility Criteria

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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.