Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics
of danicopan in participants with GA secondary to AMD. The study consists of a Screening
Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up
after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily
(bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Key Inclusion Criteria:
- Vaccination for Neisseria meningitidis.
- Capable of giving signed informed consent.
- Presentation of GA secondary to AMD in at least 1 eye
- The entire GA lesion must be > 1 μm outside of the foveal center
Key Exclusion Criteria:
- GA in the study eye due to cause other than AMD.
- Have previously received intravitreal anti-vascular endothelial growth factor
injections in study eye for intraocular vascular disease.
- Have previously received any stem cell/gene therapy for any ophthalmological condition
in either eye.
- Previous participation in interventional clinical studies for any ophthalmic
indications in the study eye regardless of route of administration within the last 3
months or 5 half-lives of the investigational product (whichever is longer).
- Presence of active ocular diseases in the study eye that in the opinion of the
Investigator compromises or confounds visual function or interferes with study
assessments.
- Known or suspected complement deficiency.
- History or presence of any medical or psychological condition that, in the opinion of
the Principal Investigator, would make the patient inappropriate for the study.
- Hypersensitivity to fluorescein sodium for injection, the investigational drug
(danicopan) or any of its excipients.
Note: Additional inclusion/exclusion criteria may apply, per protocol.