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Clinical Trial Report

Gene Therapy Trial Report

Summary

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD


NCTID NCT05407636 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Compound Name ABBV-RGX-314
Compound Description antibody similar to ranibizumab, VEGF antagonist
Sponsor AbbVie
Funder Type Industry
Recruitment Status
Recruiting
Enrollment Count 660
Results Posted Not Available

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 1.5E12 GC/eye (suprachoroidal delivery)
Dose 5

Study Record Dates


Current Stage Phase3
Submit Date 2022-01-28
Completion Date 2026-11
Last Update 2024-10-16

Participation Criteria


Eligible Age 50 Years - 89 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 128
Locations Canada,Puerto Rico,Hungary,United States,Japan,Italy,United Kingdom,France,Germany,Spain

Regulatory Information


Has US IND True
FDA Designations
Recent Updates Pivotal data expected 2026

Resources/Links