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NCT03066258 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial
A Phase 1 study, sponsored by REGENXBIO.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT03066258 is a Phase 1 study that has completed, run by REGENXBIO. The registered enrollment target is 42 participants.
The verdict
NCT03066258, a Phase 1 study, has completed, sponsored by REGENXBIO.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
Excessive vascular endothelial growth factor (VEGF) plays a key part in promoting neovascularization and edema in neovascular (wet) age-related macular degeneration (nAMD). VEGF inhibitors (anti-VEGF), including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron), have been shown to be safe and effective for treating nAMD and have demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via intravitreal injection and can be a significant burden to the patients. RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment burden of currently available therapies while maintaining vision with a favorable benefit:risk profile.
Interventions
- GENETIC RGX-314
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-03-29 |
| Est. Completion | 2021-06-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03066258
The ClinicalTrials.gov registry entry for NCT03066258 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is REGENXBIO, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RGX-314 is the first listed.
NCT03066258 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03066258 about?
NCT03066258 is a clinical study titled "Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial". Excessive vascular endothelial growth factor (VEGF) plays a key part in promoting neovascularization and edema in neovascular (wet) age-related macular degeneration (nAMD). VEGF inhibitors (anti-VEGF), including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron), have been shown ...
What is the current status of trial NCT03066258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2017-03-29. Estimated completion is 2021-06-17.
What interventions are being tested in trial NCT03066258?
The interventions under investigation include: RGX-314 (GENETIC).
Who is sponsoring clinical trial NCT03066258?
This trial is sponsored by REGENXBIO, which has 9 total clinical trials registered on ClinicalTrials.gov.
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