Status:
RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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 pu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2033
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT07007065
Start Date
November 5 2025
End Date
March 1 2033
Last Update
March 13 2026
Active Locations (80)
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1
American Vision Partners /ID# 264615
Sun City, Arizona, United States, 85351
2
Retinal Diagnostic Center /ID# 263054
Campbell, California, United States, 95008
3
The Retina Partners /ID# 263265
Encino, California, United States, 91436
4
Retina Associates of Southern California /ID# 263056
Huntington Beach, California, United States, 92647