Gene therapy for macular degeneration: is it safe years later?
NCT ID NCT01678872
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 18 people who already received RetinoStat, a gene therapy for wet age-related macular degeneration, to see if it remains safe over time. Researchers track side effects and vision changes. The goal is to understand long-term risks, not to test if the treatment works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Aug 2012
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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John Hopkins University Hospital
Baltimore, Maryland, 21287-9277, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52245, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can blocking rogue immune cells stop a leading cause of blindness?
- Can a One-Time gene injection ease the burden of wet AMD?
- A window into the eye: could functional tests predict macular degeneration progression?
- Longer-Lasting eye injection could cut treatment visits for macular disease
- Can a VR maze reveal hidden vision loss in macular degeneration?
- Can a new eye injection save vision in wet AMD?