Back to resultsA Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Primary Purpose
Age-Related Macular Degeneration
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RetinoStat
Sponsored by
About this trial
This is an interventional other trial for Age-Related Macular Degeneration
Eligibility Criteria
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
Sites / Locations
- University of Iowa Hospitals & Clinics
- John Hopkins University Hospital
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Long Term Follow up
Arm Description
Long Term follow up of patients who received RetinoStat in a previous study.
Outcomes
Primary Outcome Measures
The incidence of adverse events
The number of subjects with treatment emergent adverse events.
Secondary Outcome Measures
The change from baseline in BCVA.
The change from baseline in Best Corrective Visual Acuity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01678872
Brief Title
A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Official Title
A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2029 (Anticipated)
Study Completion Date
March 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford BioMedica
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Long Term Follow up
Arm Type
Other
Arm Description
Long Term follow up of patients who received RetinoStat in a previous study.
Intervention Type
Drug
Intervention Name(s)
RetinoStat
Intervention Description
Long Term Follow up of patients who received RetinoStat in a previous study
Primary Outcome Measure Information:
Title
The incidence of adverse events
Description
The number of subjects with treatment emergent adverse events.
Time Frame
15 years
Secondary Outcome Measure Information:
Title
The change from baseline in BCVA.
Description
The change from baseline in Best Corrective Visual Acuity.
Time Frame
15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Campochiaro, MD
Organizational Affiliation
John Hopkins University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States
Facility Name
John Hopkins University Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-9277
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
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