A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512298-28-00

Acronym

M24-528

Enrollment

272

Registered

2025-12-02

Start date

2025-12-18

Completion date

Unknown

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular age-related macular degeneration

Brief summary

Annualized intravitreal anti-VEGF injection rate from Week 6 through Week 54.

Detailed description

Change from Baseline in BCVA at Year 3., Annualized intravitreal anti-VEGF injection rate from Week 6 through Year 3., Incidence and severity of ocular AEs in the study eye and contralateral eye, Change from Baseline in area of macular atrophy based on FAF at assessed time points in the study eye

Interventions

DRUGLucentis 10 mg/ml solution for injection in pre-filled syringe

DRUGSurabgene Lomparvovec (ABBV-RGX-314)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualized intravitreal anti-VEGF injection rate from Week 6 through Week 54.	—

Secondary

Measure	Time frame
Change from Baseline in BCVA at Year 3., Annualized intravitreal anti-VEGF injection rate from Week 6 through Year 3., Incidence and severity of ocular AEs in the study eye and contralateral eye, Change from Baseline in area of macular atrophy based on FAF at assessed time points in the study eye	—

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Italy, Portugal, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026