Trial record 6 of 12 for:
"Stargardt disease"
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:
Oxford BioMedica
Information provided by (Responsible Party):
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT01736592
First received: November 26, 2012
Last updated: May 9, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
age-related macular degeneration
Stargardt macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
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: | May 9, 2013 |
| 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 May 21, 2013