This study is looking at macular neovascularization secondary to age-related macular degeneration, which is a condition where abnormal blood vessels grow under the center part of the retina, the light-sensitive tissue at the back of the eye. This happens as part of age-related macular degeneration, a disease that affects central vision and is common in older adults. The study will test a treatment called 4D-150, which is an experimental gene therapy given as a single injection into the eye. This will be compared with aflibercept, an approved medication that is also injected into the eye but needs to be given repeatedly every eight weeks. The study will also use difluprednate eye drops as an additional medication. The purpose of the study is to find out if a single injection of the experimental treatment works as well as regular injections of the approved medication in maintaining or improving vision over time.
People taking part in the study will be randomly assigned to receive either one injection of the experimental treatment or regular injections of the approved medication. Before starting the main part of the study, participants will receive one injection of the approved medication to make sure their condition responds to this type of treatment. During the study, doctors will measure vision using an eye chart and will take images of the eye to see how the condition is changing. The main measurement will be the change in vision after one year of treatment. Doctors will also track how many additional injections are needed and whether the experimental treatment can reduce the need for repeated injections compared to the standard treatment.
The study will last several years and will continue to follow participants to see how long the effects of the treatments last. Throughout the study, participants will have regular visits where their vision will be tested and their eyes will be examined. The study aims to determine whether the single injection of gene therapy can provide lasting benefits and reduce the treatment burden for people with this eye condition.



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