Purpose of this Study
We are doing this study to find out if an investigational drug called JNJ-81201887 (the study drug) is a safe and effective option for people with geographic atrophy secondary to age-related macular degeneration.
Who Can Participate?
Eligibility
Adults ages 50+ who:
- Are diagnosed with early or intermediate AMD
- Have not had eye surgery, including cataract surgery, within the last 3 months
- Have no active eye inflammation
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
- Are diagnosed with early or intermediate AMD
- Have not had eye surgery, including cataract surgery, within the last 3 months
- Have no active eye inflammation
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
Age Range
50-89
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 (fair, equal chance) to 1 of 3 groups
-- One group will get a higher dose of the study drug
-- A second group will get a lower dose of the study drug
-- A third group will get a placebo (inactive substance)
- Visit our clinic at the Duke Eye Center up to 13 times.
- Keep in touch with the study team for about 19 months
At various visits, you will have blood draws, answer some questionnaires, and have eye exams and vision tests.
- Get a random assignment (fair, equal chance) to 1 of 3 groups
-- One group will get a higher dose of the study drug
-- A second group will get a lower dose of the study drug
-- A third group will get a placebo (inactive substance)
- Visit our clinic at the Duke Eye Center up to 13 times.
- Keep in touch with the study team for about 19 months
At various visits, you will have blood draws, 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
A randomized, participant and investigator masked, placebo-controlled, multicenter, proof-of-concept study to assess the safety and efficacy of LNP023 (iptacopan) in patients with early and intermediate age-related macular degeneration
Principal Investigator
Eleonora
Lad
Protocol Number
PRO00113751
NCT ID
NCT05230537
Phase
II
Enrollment Status
OPEN TO ACCRUAL