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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
Development Status Active
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Compound Name ADVM-022
Compound Alias Ixoberogene soroparvovec
Sponsor Adverum Biotechnologies, Inc.
Funder Type Industry
Recruitment Status
Active not recruiting
Enrollment Count 69
Results Posted Not Available

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 none
Dose 1 6E10 vg/eye (selected as pivotal dose)
Dose 2 2E11 vg/eye
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase2
Submit Date 2022-09-08
Completion Date 2028-08
Last Update 2025-03-03

Participation Criteria


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

Locations


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

Regulatory Information


Has US IND True
FDA Designations Fast Track, Regenerative Medicine Advanced Therapy
Recent Updates Phase 3 non-inferiority study will evaluate a broad patient population; initiated March 2025

Resources/Links