ONL1204-GA-002 GALAXY - Clinical Trial
What is the Purpose of this Study?
People in this study will be put into different groups by chance, like picking straws. The groups will get different treatments:
- Some will get a medicine called ONL1204 in small or larger amounts every 12 or 24 weeks.
- Some will get pretend shots (called sham injections) every 12 or 24 weeks.
- Some will get a different medicine called avacincaptad pegol about once every 28 days.
There is a little more than a 50% chance of getting ONL1204, about an 18% chance of getting the pretend shots, and about a 27% chance of getting avacincaptad pegol.
The study will last about 76 weeks. During that time, people will need to visit the clinic at least 8 times. They will have tests and check-ups that are part of regular care and also for the study.
Geographic Atrophy (GA) associated with Age-Related Macular Degeneration (AMD)
Who Can Participate in the Study?
This study is for adults who are 55 years old or older. They must have a kind of eye damage called geographic atrophy, which is caused by a disease called wet age-related macular degeneration.
People in the study:
- Must not have had gene therapy for eye problems before.
- Must not be planning to have cataract surgery.
What is Involved?
This study is trying to find out if a new medicine called ONL1204 can help slow down a kind of eye damage called geographic atrophy. This damage happens because of a disease called age-related macular degeneration, or AMD.
Some people in the study will get ONL1204, and others will get something called a sham injection. A sham injection looks like a real shot in the eye, but it does not go into the eye and does not have any medicine in it. It is like a pretend shot, similar to a placebo.