Purpose of this Study
We are doing this study to measure the effect of different dosages of Danicopan (the study drug) on the progression of GA secondary to AMD compared to a placebo.
Who Can Participate?
Eligibility
Adults ages 60+ who:
- Are diagnosed with GA secondary to AMD in at least one eye
- Have never received an injection in the eye for intraocular vascular disease
- Have not had surgery to treat AMD
For more information about who can join this study, please contact the study team at DEC-RA@duke.edu.
- Are diagnosed with GA secondary to AMD in at least one eye
- Have never received an injection in the eye for intraocular vascular disease
- Have not had surgery to treat AMD
For more information about who can join this study, please contact the study team at DEC-RA@duke.edu.
What is Involved?
If you choose to join the study, you will go through a screening period to:
- Evaluate your vaccination requirements
- Have eye and vision tests
- Have blood draws
If you are eligible based on screening, you will proceed to the study drug period. During this period you will:
- Be randomly assigned (by chance, like drawing a number from a hat) to 1 of the 4 study drug groups
-- One group will take the study drug at 100 mg two times per day
-- Another group will take the study drug at 200 mg two times per day
-- Another group will take the study drug at 400 mg once per day
-- Another group will take a placebo ("sugar pill")
The study drug period will last for about 2 years. After this time, study participants can join a study extension period and receive the study drug at a known dosage if they want.
During the study, you will visit the Duke Eye Center up to 23 times. We will also visit your home up to 8 times to see how you're doing and call you on the phone at various times.
At various visits, you will have blood draws, answer questionnaires, have eye and vision tests, and electrocardiograms.
- Evaluate your vaccination requirements
- Have eye and vision tests
- Have blood draws
If you are eligible based on screening, you will proceed to the study drug period. During this period you will:
- Be randomly assigned (by chance, like drawing a number from a hat) to 1 of the 4 study drug groups
-- One group will take the study drug at 100 mg two times per day
-- Another group will take the study drug at 200 mg two times per day
-- Another group will take the study drug at 400 mg once per day
-- Another group will take a placebo ("sugar pill")
The study drug period will last for about 2 years. After this time, study participants can join a study extension period and receive the study drug at a known dosage if they want.
During the study, you will visit the Duke Eye Center up to 23 times. We will also visit your home up to 8 times to see how you're doing and call you on the phone at various times.
At various visits, you will have blood draws, answer questionnaires, have eye and vision tests, and electrocardiograms.
Study Details
Full Title
A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Principal Investigator
Majda
Hadziahmetovic
Protocol Number
PRO00109485
NCT ID
NCT05019521
Phase
II
Enrollment Status
OPEN TO ACCRUAL