A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

To join this study, you generally need to be 60 years old or older and have been diagnosed with Geographic Atrophy (GA) because of Age-related Macular Degeneration (AMD) in at least one eye.

There are also specific requirements for your eyesight and the size of the GA area in the eye being studied. Your vision needs to be within a certain range, and the GA patch must be a particular size. This helps make sure the study includes people who are likely to benefit and for whom the treatment can be safely measured.

You would not be able to join if your GA is caused by something other than AMD, or if you have certain other eye conditions like active infections, untreated glaucoma, or have had recent eye treatments or surgeries. People who have had specific body-wide treatments or previous gene therapy would also not be able to participate.

If you decide to take part, you'll receive a single injection of either the new study medicine (SAR446597) or a 'sham' treatment (which feels like an injection but contains no medicine). This injection is given into your eye. You won't know whether you've received the active medicine or the sham, as this helps ensure the results are fair.

After the injection, you will have regular check-ups at the hospital or clinic over roughly two years. These visits will involve various eye tests and assessments to monitor your vision and the health of your eye. After these two years, there will be an additional three years of follow-up visits to continue checking your eye health and safety. So, in total, your participation in the study would last for about five years.