A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients with Age-Related Macular Degeneration
Phase 1
Active, not recruiting
- Conditions
- Age-Related Macular Degeneration
- Interventions
- Registration Number
- NCT01678872
- Lead Sponsor
- Oxford BioMedica
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Long Term Follow up RetinoStat Long Term follow up of patients who received RetinoStat in a previous study.
- Primary Outcome Measures
Name Time Method The incidence of adverse events 14 years The number of subjects with treatment emergent adverse events.
- Secondary Outcome Measures
Name Time Method The change from baseline in BCVA. 14 years The change from baseline in Best Corrective Visual Acuity.
Trial Locations
- Locations (3)
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
John Hopkins University Hospital
🇺🇸Baltimore, Maryland, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States