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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736592
First Posted: November 29, 2012
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose
The purpose of the study is to examine the long term safety of an experimental gene transfer agent, SAR422459, designed to treat Stargardt Macular Degeneration.

Condition Intervention Phase
Stargardt Disease Drug: SAR422459 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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


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


Estimated Enrollment: 28
Actual Study Start Date: December 14, 2012
Estimated Study Completion Date: March 15, 2034
Estimated Primary Completion Date: March 15, 2034 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Long Term Follow up
Long Term follow up of patients who received SAR422459 in a previous study
Drug: SAR422459
Other Name: Long Term follow up of patients who received SAR422459 in a previous study

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have received a subretinal injection of SAR422459.
  • Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit.

Exclusion Criteria:

  • Did not receive SAR422459 as part of the TDU13583 protocol
  Contacts and Locations
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


Locations
United States, Oregon
Investigational Site Number 840001
Portland, Oregon, United States, 97239-3098
France
Investigational Site Number 250001
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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01736592     History of Changes
Other Study ID Numbers: LTS13588
SG1/002/11
First Submitted: November 26, 2012
First Posted: November 29, 2012
Last Update Posted: July 12, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases