A study to compare JNJ-81201887 to a sham procedure for the treatment of geographic atrophy secondary to age-related macular degeneration

This study is open to men and women aged 60 and older who have geographic atrophy caused by dry age-related macular degeneration. To qualify, the patches of eye damage must be a specific size, but they must not yet have reached the very centre of your vision (known as the fovea).

Your other eye must also have some useful sight remaining (at least enough vision to count fingers). Specialist eye scans taken during an initial screening visit will confirm whether your eyes meet the exact measurements required for the trial.

You may not be able to take part if you have had certain previous eye treatments, such as specific laser therapies or radiation therapy in the study eye. You must also be well enough to safely take the temporary steroid medicines used during the study.

Taking part in the trial lasts about one year and seven months (19 months), with the option to join a longer follow-up study afterwards. After initial screening checks, you will be randomly placed into one of three groups. Two groups receive the real gene therapy as a single injection into the eye (either a low or high dose). The third group receives a dummy 'sham' procedure, which uses a syringe without a needle to gently press against the eye so it feels similar without delivering any medicine.

To prevent swelling and inflammation, participants getting the gene therapy will also take steroid tablets for 20 days and receive a single steroid injection around the eye. Those in the dummy group will take dummy tablets and receive a dummy steroid procedure.

Throughout the study, you will attend regular clinic visits for eye checks, scans, vision tests, and blood samples. These tests help doctors monitor how your eyes and body respond. All study treatments and tests are provided free of charge, and reasonable travel and parking expenses will be reimbursed.