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Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration

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.
 
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

Tracking Information
First Submitted Date  ICMJE November 26, 2012
First Posted Date  ICMJE November 29, 2012
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE December 14, 2012
Estimated Primary Completion Date August 2034   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
The incidence of Adverse Events [ Time Frame: 15 years ]
The number and percentage of patients with treatment emergent adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
The incidence of Adverse Events [ Time Frame: 15 years ]
The number of patients with treatment emergent adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
The change from baseline in BCVA [ Time Frame: 15 years ]
The change frm baseline in Best Corrective Visual Acuity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
Official Title  ICMJE An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Stargardt's Disease
Intervention  ICMJE Drug: Long term follow up in all patients who received SAR422459 in previous study TDU13583
Blood draw for the laboratory assessment
Study Arms  ICMJE Long Term Follow up
Long term follow up in all patients who received SAR422459 in previous study TDU13583
Intervention: Drug: Long term follow up in all patients who received SAR422459 in previous study TDU13583
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 20, 2020)
27
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2012)
28
Estimated Study Completion Date  ICMJE August 2034
Estimated Primary Completion Date August 2034   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01736592
Other Study ID Numbers  ICMJE LTS13588
SG1/002/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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

Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Wilson, MD Oregon Health and Science University
Principal Investigator: José-Alain Sahel, MD Centre National d'Ophtalmologie des Quinze-Vingts
PRS Account Sanofi
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP