Contact SCGE




Clinical Trial Report

Gene Therapy Trial Report

Summary

Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD


NCTID NCT04704921 (View at clinicaltrials.gov)
Description
Indication Neovascular (Wet) Age-Related Macular Degeneration
Compound Name ABBV-RGX-314
Sponsor AbbVie
Funder Type Industry
Status
Recruiting
Enrollment Count 300

Therapy Information


Target Gene/Variant Anti-VEGF
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Genetic delivery of therapeutic protein
Route of Administration Subretinal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV8
Editor Type
Dose 1 2.5 x 10^11 GC/eye
Dose 2 5.0 x 10^11 GC/eye
Dose 3 1.0 x 10^12 GC/eye
Dose 4
Dose 5

Study Record Dates


Current Stage Phase2, Phase3
Submit Date 2021-01-08
Completion Date 2026-05
Last Update 2024-04-26

Participation Criteria


Eligible Age 50 Years - 89 Years
Standard Ages Adult, Older adult
Eligible Sex ALL

Locations


No.of Trial Sites 80
Locations United States

Regulatory Information


Has US IND True
Recent Updates Pivotal trial initiation expected H1 2025; BLA/EMA submissions H1 2026

Resources/Links