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.
Who Can Participate?
Eligibility
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.
Age Range
55-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2 Multicenter, Randomized, Double-masked, Sham-controlled, Reference-arm Study to Evaluate Efficacy and Safety of ONL1204 in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD) - ONL1204-GA-002 (GALAXY)
Principal Investigator
Majda
Hadziahmetovic
Protocol Number
PRO00117638
NCT ID
NCT06659445
Phase
II
Enrollment Status
Pending Open to Enrollment