The OnwarD
Study

A clinical study of oral investigational medication for a type of advanced age-related macular degeneration (AMD)

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What is the OnwarD Study?

This study is being done to see if a new investigational medicine can help adults with an advanced form of dry AMD called geographic atrophy (GA). GA is a progressive condition that can lead to blindness. There is currently no approved treatment for it.

Who can participate in the OnwarD Study?

Approximately 332 adults are being asked to join this study. You may be able to join if you have dry AMD in at least one eye and are 60 years or older.

There are other requirements. The study doctor will do tests to see if you meet the criteria and that the study is right for you.

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It's important for all kinds of people to join clinical studies because certain medical conditions and medications may affect people differently based on their age, sex, and race/ethnicity.

How long is the study?

The study can last up to 2 years and 3 months.

The majority of the visits will take place at the study clinic.

You may have some home visits if you wish to do so, and if your study clinic allows them.

1

SCREENING

up to 6 weeks before starting the study

You will have tests and health checks to see if the study is right for you.

2

TREATMENT

(YEAR 1 AND YEAR 2)

You will take the investigational medication or placebo during the first year and the investigational medicine (no placebo) during the second year.

3

DOSE DECREASE AND FOLLOW UP

30 days after last dose of study medicine

Before you stop taking the study medicine completely, the dose will be slowly decreased. There is one final visit for a health check after you are done taking the study medicine.

What happens during the study?

View Understanding Clinical Trials video

What tests would I have?

You will answer questions about your vision, health, and medications, and have physical exams. Blood and urine samples will be taken.

Vision tests, eye exams, imaging of the back of your eye, and other tests will be done on your eyes. Some eye tests will require dilation.

GENERAL HEALTH CHECKS AND TESTS

HEALTH INFORMATION

MEDICINE REVIEW

VITAL SIGNS

BLOOD TESTS

URINE TESTS

PHYSICAL EXAMS

You will have a heart test (ECG) about once a year during the study.

VISION AND EYE TESTS

VISION TESTS

EYE EXAMS

EYE IMAGING

Some eye tests will require your pupils to be widened with dilating eye drops to allow a better view into the back of your eye.

One eye test will require injection of a fluorescent dye to help see any leaky blood vessels in your eye.

At some visits, you will be asked to complete questionaires about your health-related quality of life and how vision problems affect your daily life.

What treatment will I receive?

The investigational medicine being studied is call danicopan [dan-IH-co-pan]. It is an oral tablet taken once or twice a day. Danicopan is being compared to placebo. A placebo looks just like the active drug but has no active ingredients.

YEAR 1

There is a 75% chance you would get danicopan.

There is a 25% chance you would get placebo.

There is a 75% chance you would get danicopan.

There is a 25% chance you would get placebo.

YEAR 2

Everyone in the study gets danicopan.

To keep the study fair, neither you nor your study doctor will know which treatment you are receiving.

What else should I know?

You will need to have been vaccinated against meningococcal infection within the past 3 years or agree to receive vaccination.

Before joining, you will be given an Informed Consent Form that explains the study. Ask any questions you may have. If you agree to join, you will give your permission by signing the form.