A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Overview
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.
Full Title of Study: “A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: March 2029
Interventions
- Drug: RetinoStat
- Long Term Follow up of patients who received RetinoStat in a previous study
Arms, Groups and Cohorts
- Other: Long Term Follow up
- Long Term follow up of patients who received RetinoStat in a previous study.
Clinical Trial Outcome Measures
Primary Measures
- The incidence of adverse events
- Time Frame: 15 years
- The number of subjects with treatment emergent adverse events.
Secondary Measures
- The change from baseline in BCVA.
- Time Frame: 15 years
- The change from baseline in Best Corrective Visual Acuity.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Oxford BioMedica
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Peter Campochiaro, MD, Principal Investigator, John Hopkins University Hospital
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