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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 : Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : August 11, 2020
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: Long term follow up in all patients who received SAR422459 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).

As the initial TDU13583 study is terminated - recruitment to this LTS13588 study is over with 27 patients enrolled.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
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
Actual Study Start Date : December 14, 2012
Estimated Primary Completion Date : August 2034
Estimated Study Completion Date : August 2034

Resource links provided by the National Library of Medicine


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: Long term follow up in all patients who received SAR422459 in previous study TDU13583
Blood draw for the laboratory assessment


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


Secondary Outcome Measures :
  1. Clinically important changes in ocular safety assessments [ Time Frame: baseline to 15 years ]
    From baseline in (TDU13583) study and from the last visit best-corrected visual acuity (BCVA), slit-lamp examination, Fundososcopy, intraocular pressure, laboratory parameters, concomitant medications

  2. Delay in retinal degeneration [ Time Frame: baseline to 15 years ]
    Measured as change from baseline in function relative to untreated contralateral eye on: BCVA, static perimetry, microperimetry, autofluorescence, optical coherence tomography (OCT)


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
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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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
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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
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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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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01736592    
Other Study ID Numbers: LTS13588
SG1/002/11
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at:

https://www.clinicalstudydatarequest.com
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases