Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
← catalyst calendarNCT04704921 · readout ≤ 134 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →. With REGENXBIO Inc..
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
671actual
Sites
89
Country
United States
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 | 2020-12-29 | actual | When the study began enrolling |
| Primary completion | Dec 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 | 2021-01-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-28 | 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
- Wet AMD
- CNV
- Neovascular AMD
- Neovascular Age-related Macular Degeneration
- Choroidal Neovascularization
Interventions
- Genetic: ABBV-RGX-314 — also filed as surabgene lomparvovec, RGX-314
- Genetic: ABBV-RGX-314 — also filed as surabgene lomparvovec, RGX-314
- Biological: Ranibizumab (LUCENTIS®) — also filed as Ranibizumab (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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