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

Korábbi kezelés

• 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.

Más betegség

• 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.
• 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.

Laborértékek

• Hypersensitivity to the investigational drug (danicopan) or any of its excipients, or to fluorescein sodium for injection.

Egyéb

• GA in the study eye due to cause other than AMD.
• 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).
• Known or suspected complement deficiency.

• 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.