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Study of Danicopan for Patients with Geographic Atrophy Due to Age-Related Macular Degeneration

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Geographic Atrophy (GA), which is a form of Age-related Macular Degeneration (AMD). AMD is an eye disease that can lead to vision loss in older adults. The study is testing a new treatment called Danicopan, also known by its code name ALXN 2040. Danicopan is taken as a film-coated tablet and is being evaluated for its effectiveness and safety in treating GA.

The purpose of this study is to find the right dose of Danicopan that can help patients with GA. Participants in the study will receive either Danicopan or a placebo, which looks like the real medication but does not contain the active substance. The study will last for a period of time, during which participants will take the medication and have regular check-ups to monitor their condition and any changes in their vision.

Throughout the study, researchers will assess how Danicopan affects the size of the GA lesions in the eye, as well as other aspects of eye health and vision. The study will also track any side effects or adverse events that participants may experience. This research aims to provide valuable information about the potential benefits and risks of using Danicopan for treating GA in patients with AMD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, eye condition, and visual acuity using specific charts.
The total area of the geographic atrophy (GA) lesion in the eye is measured to ensure it meets the study criteria.
Step 2
Medication administration
Participants receive either danicopan (ALXN2040) or a placebo. The medication is provided in the form of a film-coated tablet for oral use.
The dosage and frequency of administration are determined by the study protocol, focusing on evaluating the effects of the medication over time.
Step 3
Regular monitoring
Participants undergo regular monitoring to assess changes in the GA lesion area and other eye health indicators.
These assessments occur at specified intervals, including baseline, week 52, and week 104, using various eye examination techniques.
Step 4
Safety and efficacy evaluation
The study evaluates the safety and efficacy of danicopan by monitoring for any adverse events or changes in eye health.
Participants' plasma concentration of the medication is measured to understand how the body processes it.
Step 5
Completion of study
The study is expected to conclude by August 2025, with final assessments conducted to evaluate the long-term effects of the treatment.
Participants' experiences and outcomes contribute to understanding the potential benefits and risks of danicopan for treating GA secondary to age-related macular degeneration.

Who can join the trial?

5 criteria

Must be **60 years or older**, whether male or female.
Must have **Geographic Atrophy (GA)**, which is a condition affecting the eye, caused by **Age-related Macular Degeneration (AMD)**, in at least one eye.
The eye being studied must have a specific range of **Visual Acuity (VA)**, which is a measure of how well you can see, between 20/20 and 20/320, using a special chart for eye tests.
The total area of the **GA lesion**, which is the damaged part of the eye, must be between 0.5 to 17.76 square millimeters per eye. If there are multiple damaged areas, at least one must be 0.5 square millimeters or larger.
The entire **GA lesion** must be more than 1 micrometer away from the center of the **fovea**, which is the part of the eye responsible for sharp vision.

Who cannot join the trial?

8 criteria

Patients who have any other eye diseases that could affect the study results.
Patients who have had eye surgery within the last three months.
Patients who are currently using other treatments for their eye condition that might interfere with the study.
Patients with a history of severe allergic reactions to medications.
Patients who have participated in another clinical trial within the last 30 days.
Patients with any serious health conditions that could make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Axon Clinical s.r.o.
Verified
Prague, Czechia
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy

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Investigated drugs

Danicopan (ALXN2040) is a medication being studied for its potential to treat geographic atrophy, a condition that affects the eyes and is related to age-related macular degeneration. The trial aims to find the right dose of danicopan and to understand how safe and effective it is for patients with this eye condition.

Danicopan

What is already known about the treatment

Danicopan – Danicopan is administered orally and is currently being studied in clinical trials for its potential use in treating geographic atrophy secondary to age-related macular degeneration. It is not yet widely recognized in medical literature as a standard treatment, as it is still under investigation. The main therapeutic indication for danicopan is to slow the progression of geographic atrophy in patients with AMD. At the molecular level, danicopan works by inhibiting a component of the complement system, which is part of the immune system that can contribute to inflammation and tissue damage in the eye. It is classified pharmacologically as a complement inhibitor.

Investigated diseases

Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) – Geographic atrophy is an advanced form of age-related macular degeneration, a common eye condition among older adults. It involves the progressive degeneration of the macula, the central part of the retina responsible for sharp vision. Over time, this leads to the formation of atrophic lesions, or areas where retinal cells have died, resulting in a gradual loss of central vision. The condition typically affects both eyes, although not always at the same rate. As the disease progresses, individuals may experience difficulties with tasks that require detailed vision, such as reading or recognizing faces. The progression of geographic atrophy can vary, with some people experiencing a slow decline in vision, while others may notice more rapid changes.