Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long
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 Neovascul
| Condition(s) | Neovascular Age-related Macular Degeneration |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 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 |
| Who can participate | 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 S |
| Ages | 50 Years |
| Sex | All |
| Lead sponsor | AbbVie |
| Locations | Mesa, Arizona, United States; Sun City, Arizona, United States; Campbell, California, United States; Encino, California, United States; Huntington Beach, California, United States; Mountain View, California, United States (+122 more sites) |
| Start date | 2025-11-05 |
| NCT ID | NCT07007065 |
| Official listing | https://clinicaltrials.gov/study/NCT07007065 |