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Clinical Trial Report

Gene Therapy Trial Report

Summary

Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]


NCTID NCT05536973 (View at clinicaltrials.gov)
Description
Indication Neovascular (Wet) Age-Related Macular Degeneration
Compound Name Ixoberogene soroparvovec (ADVM-022)
Sponsor Adverum Biotechnologies, Inc.
Funder Type Industry
Status
Active not recruiting
Enrollment Count 69

Therapy Information


Target Gene/Variant Codon optimized aflibercept
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Genetic delivery of therapeutic protein
Route of Administration Intravitreal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV.7m8
Editor Type
Dose 1 6 x 10^10 vg/eye (selected as pivotal dose)
Dose 2 2 x 10^11 vg/eye
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase2
Submit Date 2022-09-08
Completion Date 2028-11
Last Update 2024-01-08

Participation Criteria


Eligible Age >=50 Years
Standard Ages Adult, Older adult
Eligible Sex ALL

Locations


No.of Trial Sites 39
Locations United States,United Kingdom,France

Regulatory Information


Has US IND True
Recent Updates H1 2025: Initiation of Phase III trial

Resources/Links