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:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01736592
First received: November 26, 2012
Last updated: October 14, 2016
Last verified: October 2016
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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: Open Label |
| 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:
Genetics Home Reference related topics:
Stargardt macular degeneration
age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
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 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | November 2033 |
| Estimated Primary Completion Date: | November 2033 (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| 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
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
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
| 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: | October 14, 2016 |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 25, 2017