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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 January 2024 |
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Main ID: |
NCT01736592 |
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Date of registration:
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26/11/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
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Scientific title:
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An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration |
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Date of first enrolment:
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December 14, 2012 |
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Target sample size:
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27 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01736592 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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France
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United States
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Contacts
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Name:
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David Wilson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Name:
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José-Alain Sahel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre National d'Ophtalmologie des Quinze-Vingts |
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Key inclusion & exclusion 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.
Exclusion Criteria:
The following would exclude Patients from participation in the study:
1. Did not receive SAR422459 as part of the TDU13583 protocol.
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stargardt's Disease
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Intervention(s)
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Drug: Long term follow up in all patients who received SAR422459 in previous study TDU13583
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Primary Outcome(s)
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The incidence of Adverse Events
[Time Frame: 15 years]
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Secondary Outcome(s)
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Clinically important changes in ocular safety assessments
[Time Frame: baseline to 15 years]
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Delay in retinal degeneration
[Time Frame: baseline to 15 years]
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Secondary ID(s)
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LTS13588
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2012-001990-95
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SG1/002/11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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