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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.

What is the Condition Being Studied?

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.

Grupo etario
Adultos

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.

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
Especialista en oftalmología
Protocol Number
IRB: PRO00117638
NCT: NCT06659445
Phase
Phase II
ClinicalTrials.gov
Estado de inscripción
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