Proof of concept and dose-finding study of danicopan in patients with geographic atrophy secondary to AMD
- Conditions
- Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)Age-Related Macular Degeneration(AMD)/Geographic Atrophy(GA)
- Registration Number
- JPRN-jRCT2051220074
- Lead Sponsor
- Kanemoto Koji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 13
1.Documentation of vaccination for Neisseria meningitidis.
2.Capable of giving signed informed consent.
3.Presentation of GA secondary to AMD in at least 1 eye with new inclusion criterion
4.The entire GA lesion must be extrafoveal without foveal involvement
1.GA in either eye due to cause other than AMD.
2.Have previously received intravitreal anti-vascular endothelial growth factor injections in study eye.
3.Have previously received any complement/stem cell/gene therapy for any ophthalmological condition.
4.Previous participation in interventional clinical studies for treatment of drusen, nascent GA or GA (except vitamins or minerals) irrespective of route of administration (ocular or systemic) in either eye.
5.Presence of active ocular diseases in either eye that in the opinion of the Investigator compromises or confounds visual function or interferes with study assessments.
6.Known or suspected complement deficiency.
7.History or presence of any clinically relevant co-morbidities or any uncontrolled conditions.
8.Hypersensitivity to fluorescein sodium for injection, the investigational drug (danicopan) or any of its excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline To Week 52 In The Square Root (sqrt) Of Total GA Lesion Area In The Study Eye As Measured By Fundus Autofluorescence (FAF)
- Secondary Outcome Measures
Name Time Method