Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration

NCTID	NCT06856577 (View at clinicaltrials.gov)
Description	This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to an active comparator. The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured at an average of Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study. (Show More)
Development Status	Active
Indication	Neovascular 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	Recruiting
Enrollment Count	284
Results Posted	Not Available

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

No.of Trial Sites	6
Locations	United States

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