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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 332

Inclusion Criteria

Key Inclusion Criteria:
• Age = 60 years, male or female
• Presentation of GA secondary to AMD in at least 1 eye.
• Study eye must have the specified VA (range of 84 to 24 letters; 20/20 to 20/320) using Early Treatment Diabetic Retinopathy Study charts at starting distance of 4 meters.
• Total GA lesion area of 0.5 to 17.76 mm2 (~0.2 to 7 disc area [DA]) per eye measured by FAF. If GA is multifocal, at least one focal lesion must be = 0.5 mm2 (~0.2 DA).
• The entire GA lesion must be >1 µm outside of the foveal center

Note: Additional inclusion/exclusion criteria may apply, per protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 232

Exclusion Criteria

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 or 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
• Hypersensitivity to the investigational drug (danicopan) or any of its excipients, or to fluorescein sodium for injection
• 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 or unable to comply with study procedures or put the patient at undue risk or confound the results of the study.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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