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	Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD). Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide. Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. (Show More)
Development Status	Active
Indication	Neovascular Age-related Macular Degeneration
Disease Ontology Term	DOID:10871
Drug Product Name	ABBV-RGX-314
Drug Product Alias	surabgene lomparvovec
Drug Product Description	antibody similar to ranibizumab, VEGF antagonist
Sponsor	AbbVie
Funder Type	Industry
Recruitment Status	Recruiting (Click here for study contact information)
Enrollment Count	561 (ESTIMATED)
Results Posted	Not Available

Therapy Information

Target Gene/Variant	Anti-VEGF
Therapeutic Modality	Gene transfer
Therapy Route	in vivo
Mechanism of Action	Genetic delivery of therapeutic protein
Route of Administration	Subretinal
Drug Product Type	Viral vector
Gene Delivery System Type	Viral transduction
Vector Type 🔄	Adeno-associated virus
Viral Vector Subtype	AAV8
Dose 1 🔄	Phase 1/2 doses: 3E9 GC/eye (n=5); 1E10 GC/eye (n=5); 6E10 GC/eye (n=6); 1.6E11 GC/eye (n=11); 2.5E11 GC/eye (n=10)
Dose 2 🔄	Phase 2 doses (suprachoroidal delivery): 2.5E11 GC/eye, 5.0E11 GC/eye, 1.0E12 GC/eye, 1.5E12 GC/eye

Study Record Dates

Current Phase	Phase3
Submit Date	2025-05-28
Completion Date	2033-03
Last Update 🔄	2026-07-07

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 🔄	128
Locations 🔄	Puerto Rico,Hungary,United States,Czechia,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; REGENXBIO expects to announce topline data with AbbVie from the ATMOSPHERE and ASCENT pivotal trials of sura-vec in wet AMD using subretinal delivery in Q4 2026

Resources/Links

Clinical Publications 🔄

Gene therapy for neovascular age-related macular degeneration by subretinal delivery of RGX-314: a phase 1/2a dose-escalation study
(Presentation) Subretinal Delivery of Investigational ABBV-RGX-314* as a Gene Therapy for nAMD One-year Results of a Fellow Eye Bilateral Dosing Study
(Presentation) Suprachoroidal Delivery of Investigational ABBV-RGX-314 for Neovascular AMD: Results from the Phase II Study - Retina, January 2024
(Presentation) Subretinal Delivery of Investigational Sura-vec Gene Therapy for Neovascular Age-Related Macular Degeneration: Long-Term Follow-Up of Phase 1/2a Participants -ASRS 2026