A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

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Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

60 Years

Maximum Age

N/A

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.

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