A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Sponsored by Alexion
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the Participation Requirements?
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.
- Use of any investigational medicinal product (ie, participation in interventional
clinical studies for any ophthalmic indications) or use of any regulatory approved
treatment for GA in the study eye regardless of route of administration within the
last 3 months or 5 half-lives of the last dose of the investigational or commercial
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.