AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized, double masked, placebo-controlled, multicenter, dose-range finding study to assess the efficacy and safety of FWY003 in patients with geographic atrophy secondary to age-related macular degeneration

This research study is investigating a new medication called FWY003 for people with geographic atrophy. This is a common eye condition linked to aging that can cause 'blind spots' to develop in your vision. The main goal is to find out if FWY003 can help stop these blind spots from getting bigger over an 18-month period. Researchers also want to make sure the treatment is safe and doesn't cause too many side effects, both in the eye and generally in the body. Different amounts (doses) of FWY003 are being tested to see which works best. Some participants will receive a dummy treatment (placebo) for comparison.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

142

Start

04 May 2026

Geographic atrophy secondary to age-related macular degeneration

What is this study about?

This research is specifically looking at Geographic Atrophy (GA), a condition that can affect your central vision as you get older. GA is part of 'age-related macular degeneration' (AMD) and causes a gradual loss of vision in the middle of what you see, making it harder to recognise faces, read, or drive. Currently, there aren't many widely available treatments for GA, so finding new options is really important.

The study is testing a new drug called FWY003. Researchers want to understand if this new treatment can slow down the growth of the 'blind spots' (also called lesions) that develop in the eye due to GA. They will compare how quickly these spots grow in people who receive FWY003 versus those who receive a 'dummy' treatment (placebo). This helps them to see if FWY003 is truly making a difference. They will also be looking very carefully at how safe the treatment is and if it causes any unwanted side effects, both in your eyes and in your general health.

This is a 'Phase II' study, which means it's an early stage of testing this new treatment in people. It will help researchers decide if FWY003 is promising enough to be studied in a much larger group of people later on. The information gathered from this study will help us understand more about GA and potentially lead to new ways to help people living with this condition.

Key takeaways

Targets geographic atrophy, a severe eye condition.
Investigates a new drug, FWY003, given via eye injections.
Aims to slow down the growth of 'blind spots' in vision.
Compares FWY003 to a dummy treatment (placebo).
Involves regular eye exams and health checks over 18 months.
This is an early-stage study to test safety and effectiveness.

Who may be eligible?

To join this study, you usually need to meet certain requirements. The study is open to both men and women, aged 18 years and older – there is no upper age limit.

Specific details about your eye health will be very important. For example, you would need to have a confirmed diagnosis of geographic atrophy in at least one eye. The doctors may also need to check the size and location of the blind spots in your eye to make sure they fit the study's requirements. They will also look at your overall health to make sure you are well enough to take part.

It's important to remember that these are just a few general points. A doctor on the study team would need to review your full medical history and perform special eye tests to tell you for sure if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with geographic atrophy (GA) in at least one eye?
Are you generally in good health?
Are you comfortable with regular eye exams and potential eye injections?
Are you able to commit to 18 months of study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for about 18 months. During this time, you would have regular visits to the clinic. These visits would include detailed eye examinations, where doctors will check your vision very carefully using special charts and equipment. They will also take pictures of your eye to measure the 'blind spots' caused by your geographic atrophy.

You would receive either the study medication (FWY003) or a 'dummy' treatment (placebo). Neither you nor your study doctor would know which one you are receiving – this is called 'double masked' and helps to make the study results fair. The treatment would likely be given as an injection into the eye, a common way to treat eye conditions. You'd also have general health checks, including blood tests, heart checks (ECG), and physical examinations to make sure you're staying well and to monitor for any side effects.

After 18 months, your active participation in the study would usually end, though there might be a follow-up visit. The study team would explain the exact schedule of visits and procedures in detail before you make any decisions.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as receiving a new treatment that could help slow down your geographic atrophy, or at least help researchers learn more about the condition. However, there's no guarantee the treatment will improve your vision or even stop the progression of your condition. As with any medication or procedure, FWY003 could have side effects, both in your eye (like discomfort or infection from injections) and in your general body. These will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Bulgaria
—
Unverified
Romania
—
Unverified
Germany
—
Unverified
Czechia
—
Unverified
Spain
—
Unverified
Poland
—
Unverified
Italy
—
Unverified
Hungary
—
Unverified
France

Common questions

What is geographic atrophy?

It's an advanced form of age-related macular degeneration (AMD) that causes blind spots in your central vision, making it hard to see details.

What is FWY003?

FWY003 is a new experimental medication being tested to see if it can help slow down the growth of these blind spots.

Will I get the actual drug or a placebo?

You might get the actual drug FWY003 or a dummy treatment (placebo). Neither you nor your doctor will know which one you're receiving during the study.

How long will the study last if I join?

If you join, your active participation in the study is expected to last for about 18 months.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, without affecting your regular medical care.