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):
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT01736592
First received: November 26, 2012
Last updated: February 14, 2014
Last verified: February 2014
  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

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:


Further study details as provided by Oxford BioMedica:

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:
  • The change from baseline in BCVA [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    The change frm baseline in Best Corrective Visual Acuity


Estimated Enrollment: 28
Study Start Date: December 2012
Estimated Study Completion Date: November 2028
Estimated Primary Completion Date: November 2028 (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 SG1/001/10 to Week 48 or undergone an early discontinuation visit.

Exclusion Criteria:

  • Did not receive StarGen™as part of the SG1/001/10 protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736592

Locations
United States, Oregon
Dr Wilson
Portland, Oregon, United States, 97239
France
Centre National d'Ophtalmologie des Quinze-Vingts
Paris, France, 75012
Sponsors and Collaborators
Oxford BioMedica
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: Oxford BioMedica
ClinicalTrials.gov Identifier: NCT01736592     History of Changes
Other Study ID Numbers: SG1/002/11
Study First Received: November 26, 2012
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014