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: 2025-12-26
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
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RECRUITING
PHASE3
561 participants
INTERVENTIONAL
2025-11-05
2033-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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Surabgene Lomparvovec (ABBV-RGX-314)
subretinal injection
Ranibizumab Control
intravitreal injection
Other Intervention Names
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Eligibility Criteria
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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
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Retina Consultants of Southern Colorado /ID# 263284
Colorado Springs, Colorado, United States
Colorado Retina Associates /ID# 263247
Lakewood, 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
Retina Specialist /ID# 264633
Towson, Maryland, 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
Star Retina - Burleson /ID# 266386
Burleson, Texas, United States
Retina Centre of Ottawa /ID# 263803
Ottawa, Ontario, Canada
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152
Barcelona, , Spain
Hospital Universitario 12 de Octubre /ID# 263544
Madrid, , Spain
The Retina Clinic London /ID# 266156
London, Greater London, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 265854
Liverpool, Merseyside, United Kingdom
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2024-512298-28-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-528
Identifier Type: -
Identifier Source: org_study_id