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A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
EU CTIS ID: 2023-508571-37-00
What this study is testing
This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Canada
- Australia
- Korea, Republic of
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; Canada; Australia; Korea, Republic of; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.