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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
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)

Study Record Dates


Current Stage Phase3
Submit Date 2025-05-28
Completion Date 2033-03
Last Update 🔄 2026-03-25

Participation Criteria


Eligible Age >=50 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
Inclusion Criteria: * Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \[Week -6\]) in the study eye. * Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\^2) * Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator) Exclusion Criteria: * CNV or macular edema in the study eye that is secondary to any causes other than AMD * Study eye with nAMD diagnosed \> 4 years from Screening Visit 1 * Any retinal pigment epithelial detachment \> 400 μm or any pigment epithelial detachment \> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center. * Any subretinal hemorrhage in the study eye \> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center * Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 🔄 88
Locations 🔄 Puerto Rico,Hungary,United States,United Kingdom,Portugal,Spain,Greece,Canada,Austria,Belgium,Italy,Israel,Bulgaria,France,Germany,Croatia

Regulatory Information


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

Resources/Links