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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01736592
First received: November 26, 2012
Last updated: February 4, 2015
Last verified: February 2015
History of Changes
  Purpose

The purpose of the study is to examine the long term safety of an experimental gene transfer agent, StarGen™, designed to treat Stargardt Macular Degeneration.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of StarGen™ in Patients With Stargardt's Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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


Secondary Outcome Measures:
  • Delay in retinal degeneration [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    The change from baseline function relative to the contralateral eye utilising retinal analytical techniques
Estimated Enrollment: 28
Study Start Date: December 2012
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Long Term Follow up
Long Term follow up of patients who received StarGen™ in a previous study
 Drug: StarGen
Other Name: Long Term follow up of patients who received StarGen™ in a previous study

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Did not receive StarGen™as part of the TDU13583 protocol
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01736592     History of Changes
Other Study ID Numbers: LTS13588, SG1/002/11
Study First Received: November 26, 2012
Last Updated: February 4, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 02, 2015