A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Sponsor
Oxford BioMedica (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01678872
Collaborator
(none)
18
3
1
199
6
0
Study Details
Study Description
Brief Summary
The purpose of this study is to examine the long term safety of an experimental gene transfer agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Study Start Date
:
Aug 1, 2012
Anticipated Primary Completion Date
:
Mar 1, 2029
Anticipated Study Completion Date
:
Mar 1, 2029
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Long Term Follow up Long Term follow up of patients who received RetinoStat in a previous study. |
Drug: RetinoStat
Long Term Follow up of patients who received RetinoStat in a previous study
|
Outcome Measures
Primary Outcome Measures
- The incidence of adverse events [15 years]
The number of subjects with treatment emergent adverse events.
Secondary Outcome Measures
- The change from baseline in BCVA. [15 years]
The change from baseline in Best Corrective Visual Acuity.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Must have received a subretinal injection of RetinoStat
-
Must have been enrolled in Protocol RS1/001/10
Exclusion Criteria:
- Did not receive RetinoStat® as part of the RS1/001/10 protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52245 |
2 | John Hopkins University Hospital | Baltimore | Maryland | United States | 21287-9277 |
3 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oxford BioMedica
Investigators
- Principal Investigator: Peter Campochiaro, MD, John Hopkins University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT01678872
Other Study ID Numbers:
- RS1/002/11
First Posted:
Sep 5, 2012
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms: