Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
← catalyst calendarNCT05407636 · readout ≤ 72 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →. With REGENXBIO Inc..
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
735actual
Sites
181
Countries
Canada, France, Germany +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-13 | actual | When the study began enrolling |
| Primary completion | Oct 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-06-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- AMD
- nAMD
- Wet Age-related Macular Degeneration
- wAMD
- WetAMD
- CNV
Interventions
- Genetic: ABBV-RGX-314 Dose 1 — also filed as RGX-314, surabgene lomparvovec
- Genetic: ABBV-RGX-314 Dose 2 — also filed as RGX-314, surabgene lomparvovec
- Biological: Aflibercept (EYLEA®) — also filed as Eylea (anti-VEGF agent)
Primary outcomes
what the primary-completion date above is the date OFMean change from baseline in Best Corrected Visual Acuity (BCVA)
measured At Week 54
Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs
measured Week 50
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