Purpose of this Study
We are doing this study to find out if an investigational drug called tinlarebant (the study drug) is safe and useful for treating geographic atrophy (GA).
Who Can Participate?
Eligibility
Adults ages 60-85 who:
- Are diagnosed with geographic atrophy with lesions
- Do not have diabetic macular edema or another form of macular disease
- Have no inflammatory disease
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
- Are diagnosed with geographic atrophy with lesions
- Do not have diabetic macular edema or another form of macular disease
- Have no inflammatory disease
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
Age Range
60-85
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join the study, you will:
- Get a random assignment (like a coin flip) to take the study drug or a placebo (inactive substance)
- Keep in touch with the study team for about 2 years and 2 months
- Visit our clinic at the Duke Eye Center up to 11 times
At various visits, you will have blood tests, answer some questionnaires, and have eye exams and vision tests.
- Get a random assignment (like a coin flip) to take the study drug or a placebo (inactive substance)
- Keep in touch with the study team for about 2 years and 2 months
- Visit our clinic at the Duke Eye Center up to 11 times
At various visits, you will have blood tests, answer some questionnaires, and have eye exams and vision tests.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX study) - LBS-008-CT05
Principal Investigator
Eleonora
Lad
Protocol Number
PRO00113726
NCT ID
NCT05949593
Phase
III
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF