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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
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of Adverse Events [ Time Frame: 15 years ]
    The number of patients with treatment emergent adverse events


Secondary Outcome Measures :
  1. Delay in retinal degeneration [ Time Frame: 15 years ]
    The change from baseline function relative to the contralateral eye utilising retinal analytical techniques


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
United States, Oregon
Investigational Site Number 840001 Recruiting
Portland, Oregon, United States, 97239-3098
France
Investigational Site Number 250001 Recruiting
Paris, France, 75012
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: David Wilson, MD Oregon Health and Science University
Principal Investigator: José-Alain Sahel, MD Centre National d'Ophtalmologie des Quinze-Vingts
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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