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Clinical Trial Report

Gene Therapy Trial Report

Summary

Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD


NCTID NCT04704921 (View at clinicaltrials.gov)
Description
Indication AMD, nAMD, Wet Age-related Macular Degeneration, wAMD, Wet AMD, CNV, Neovascular AMD, Neovascular Age-related Macular Degeneration, Choroidal Neovascularization
Compound Name ABBV-RGX-314
Sponsor AbbVie
Funder Type Industry
Status
Recruiting
Enrollment Count 540

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 none
Dose 1 2.5E11 GC/eye
Dose 2 5.0E11 GC/eye
Dose 3 1.0E12 GC/eye
Dose 4
Dose 5

Study Record Dates


Current Stage Phase2, Phase3
Submit Date 2021-01-08
Completion Date 2026-05
Last Update 2025-01-29

Participation Criteria


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

Locations


No.of Trial Sites 91
Locations United States

Regulatory Information


Has US IND True
Recent Updates Pivotal data expected 2026

Resources/Links