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)
NCT ID: NCT07007065
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
561 participants
INTERVENTIONAL
2025-11-05
2033-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
NCT04704921
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD
NCT05210803
RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)
NCT04514653
RGX-314 Gene Therapy Pharmacodynamic Study for Neovascular Age-related Macular Degeneration (nAMD)
NCT04832724
A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
NCT06961370
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surabgene Lomparvovec (ABBV-RGX-314) Dose 1
Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time.
Surabgene Lomparvovec (ABBV-RGX-314)
subretinal injection
Surabgene Lomparvovec (ABBV-RGX-314) Dose 2
Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time.
Surabgene Lomparvovec (ABBV-RGX-314)
subretinal injection
Ranibizumab Control Group
Ranibizumab administered via intravitreal injection as needed PRN
Ranibizumab Control
intravitreal injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surabgene Lomparvovec (ABBV-RGX-314)
subretinal injection
Ranibizumab Control
intravitreal injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
American Vision Partners /ID# 264615
Sun City, Arizona, United States
Retinal Diagnostic Center /ID# 263054
Campbell, California, United States
The Retina Partners /ID# 263265
Encino, California, United States
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
Sacramento, California, United States
Retina Consultants of Southern Colorado /ID# 263284
Colorado Springs, Colorado, United States
Colorado Retina Associates /ID# 263247
Lakewood, Colorado, United States
Advanced Vision Surgery Center /ID# 264208
Longmont, Colorado, United States
Advanced Research, LLC /ID# 276526
Deerfield Beach, Florida, United States
Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
Fort Myers, Florida, United States
Florida Retina Institute - Lake Mary /ID# 263288
Lake Mary, Florida, United States
Southeast Retina Center /ID# 263264
Augusta, Georgia, United States
Springfield Clinic Main Campus /ID# 265202
Springfield, Illinois, United States
Wolfe Eye Clinic - West Des Moines /ID# 263270
West Des Moines, Iowa, United States
The Retina Care Center /ID# 263263
Baltimore, Maryland, United States
Retina Specialist /ID# 264633
Towson, Maryland, United States
Associated Retinal Consultants /ID# 263289
Royal Oak, Michigan, United States
Erie Retina Research /ID# 263287
Erie, Pennsylvania, United States
Charleston Neuroscience Institute /ID# 264037
Bluffton, South Carolina, United States
Charleston Neuroscience Institute /ID# 276425
Charleston, South Carolina, United States
Retina Consultants of South Carolina - Ladson /ID# 277596
Ladson, South Carolina, United States
Retina Consultants of America /ID# 264038
Mt. Pleasant, South Carolina, United States
Austin Clinical Research, LLC /ID# 263229
Austin, Texas, United States
Star Retina - Burleson /ID# 266386
Burleson, Texas, United States
Retina Consultants of Texas - Westover /ID# 264209
San Antonio, Texas, United States
Medizinische Universitaet Innsbruck /ID# 264502
Innsbruck, Tyrol, Austria
Kepler Universitaetsklinikum GmbH /ID# 264493
Linz, Upper Austria, Austria
Medical Center -Vereya /ID# 275728
Stara Zagora, , Bulgaria
Retina Centre of Ottawa /ID# 263803
Ottawa, Ontario, Canada
Hopital Edouard Herriot /ID# 265072
Lyon, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu /ID# 265077
Nantes, Pays de la Loire Region, France
Centre Hospitalier Intercommunal de Creteil /ID# 265080
Créteil, Val-de-Marne, France
Universitaetsklinikum Freiburg /ID# 275449
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen /ID# 264283
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Bonn /ID# 264279
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284
Lübeck, Schleswig-Holstein, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 264280
Hamburg, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 276032
Rome, Roma, Italy
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179
Majadahonda, Madrid, Spain
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152
Barcelona, , Spain
Hospital Universitario 12 de Octubre /ID# 263544
Madrid, , Spain
Gloucestershire Royal Hospital /ID# 276072
Gloucester, Gloucestershire, United Kingdom
The Retina Clinic London /ID# 266156
London, Greater London, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 265854
Liverpool, Merseyside, United Kingdom
Bristol Eye Hospital /ID# 266155
Bristol, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-512298-28-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-528
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.