This study involves people with neovascular age-related macular degeneration, a condition where abnormal blood vessels grow under the central part of the retina at the back of the eye, which can lead to vision loss. The study will test a treatment called surabgene lomparvovec, also known as ABBV-RGX-314, which is a gene therapy given as a single injection under the retina. This treatment is designed to help the eye produce its own medicine that blocks the growth of abnormal blood vessels. The study will compare this gene therapy to ranibizumab, which is an approved medicine given as repeated injections into the eye to treat this condition.
The purpose of this study is to find out how many injections people need after receiving the gene therapy compared to those who continue getting regular injections of ranibizumab, and to see how well the gene therapy works in preserving vision over time in a setting that is similar to everyday medical practice. The study will also look at the safety of the gene therapy and measure any side effects that may occur in the treated eye or the other eye. Additionally, the study will check for changes in areas of damage in the central part of the retina.
People taking part in the study will be randomly assigned to receive either the gene therapy or ranibizumab. Those who receive the gene therapy will have it injected under the retina during a surgical procedure, while those in the comparison group will receive ranibizumab injections into the eye as needed based on how their condition responds. During the first year, people will be monitored closely and receive additional injections if needed according to specific guidelines. After the first year, the treatment schedule will follow a more flexible approach that reflects how treatment is typically managed in regular clinics. The study will last for several years to see how well vision is maintained over the long term.
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