Contact SCGE




Gene Therapy Trial Report

Summary

Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)


NCTID NCT07007065 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Neovascular Age-related Macular Degeneration
Disease Ontology Term DOID:10871
Compound Name ABBV-RGX-314
Compound Alias surabgene lomparvovec
Compound Description antibody similar to ranibizumab, VEGF antagonist
Sponsor AbbVie
Funder Type Industry
Recruitment Status
Enrollment Count 561 (ESTIMATED)
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 2025-05-28
Completion Date 2033-03
Last Update 2025-12-04

Participation Criteria


Eligible Age >=50 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 11
Locations United States

Regulatory Information


Has US IND True
FDA Designations
Recent Updates Another Phase 3 study (NCT05407636) is active, enrollment is completed

Resources/Links