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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: Completed Phase 1 study, sponsored by REGENXBIO.
NCT03066258 is a Phase 1 study that has completed, run by REGENXBIO. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants with ocular and non-ocular AEs and SAEs through 26 weeks (24 weeks following RGX-314 administration)
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 |
What the finished NCT03066258 record still lists
NCT03066258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which RGX-314 is the first listed.
NCT03066258 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03066258's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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