Purpose of this Study
People in this study will be part of it for about 110 weeks, which is a little more than 2 years. During that time, they will need to visit the study clinic at least 30 times. At each visit, they will have tests and check-ups that are part of their regular care and also for the study.
Who Can Participate?
Eligibility
People in this study must:
- Be 50 years old or older.
- Have never had treatment for their eye condition before.
- Have never had a problem called retinal detachment, which is when part of the eye pulls away from where it should be.
Age Range
50-110
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 how well a new medicine called 4D-150 works compared to a medicine called Eylea in adults who have a kind of eye disease called wet age-related macular degeneration (wet AMD). The medicine is given as a shot directly into the eye. The study also wants to make sure the new medicine is safe and lasts a long time.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal
Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-1) - 4D-150-C003
Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-1) - 4D-150-C003
Principal Investigator
Majda
Hadziahmetovic
Protocol Number
PRO00117562
NCT ID
NCT06864988
Phase
III
Enrollment Status
Pending Open to Enrollment