Contact SCGE
Your email
Message
Send
SCGE Consortium Home
About SCGE TCDC
Contact Us
License
Home
Gene Therapy Trial Browser
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
Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
(Show More)
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
Clinical Publications
(Presentation) Addressing Unmet Needs for Patients with Wet AMD - AAO 2024
(Presentation) Ixoberogene Soroparvovec (Ixo-vec) IVT Gene Therapy for Neovascular AMD: First Time 26-Week Interim Analysis Results from the Phase 2 LUNA Study - ASRS 2024
Safety and efficacy of ixoberogene soroparvovec in neovascular age-related macular degeneration in the United States (OPTIC): a prospective, two-year, multicentre phase 1 study
News and Press Releases
Adverum Biotechnologies Initiates ARTEMIS Phase 3 Study Evaluating Ixo-vec for Wet AMD
SEC Form 10-Q: Q3 2024
Adverum Biotechnologies Announces Positive 52-Week LUNA and 4-Year OPTIC Results, and Provides Key Pivotal Program Design Elements
Preclinical Publications
Preclinical Evaluation of ADVM-022, a Novel Gene Therapy Approach to Treating Wet Age-Related Macular Degeneration
Related NCTID
Phase 2: NCT04418427 (for Diabetic Macular Edema)
Phase 3: NCT06856577
Phase 1: NCT03748784