Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

FWY003 in Geographic Atrophy Secondary to Age-Related Macular Degeneration in Patients

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is studying geographic atrophy, a form of eye damage that can happen with age-related macular degeneration. The treatment being tested is FWY003, taken by mouth as a capsule. Some participants will receive placebo instead. The purpose of the study is to see how different doses of FWY003 may affect the eye disease and to check its safety.

The study will compare FWY003 with placebo in people with this eye condition. It is a randomized study, which means the treatment is assigned by chance, and double masked, which means neither the participants nor the study team know who receives FWY003 or placebo during the study. Over time, the study follows changes in the damaged area in the eye and also watches for side effects and other health changes. The study lasts for many months and includes regular visits during which eye health and general well-being are reviewed.

The research process

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

  1. Step 1

    Study treatment begins

    You receive the study treatment as oral capsules by mouth.

    The study includes FWY003, which is the test medicine and contains FWY003 tosilate, and a placebo, which looks like the study medicine but has no active medicine.

    The study is randomized, which means the study treatment is assigned by chance.

    The study is double masked, which means you and the study team do not know whether you are receiving FWY003 or placebo.

    The study is multicenter, which means it is carried out at more than one study site.

  2. Step 2

    Study treatment schedule

    The source data list FWY003 as an oral capsule, but they do not provide a clear dose amount, dosing frequency, or treatment duration.

    The source data list placebo to FWY003, but they do not provide a dose, frequency, or duration for the placebo.

    No other medicine schedule is given in the source data.

  3. Step 3

    Monthly study follow-up through month 18

    Your progress is followed from baseline, which means the starting point of the study, through month 18.

    The main study measure is the change in ga lesion area in the study eye from baseline to month 18. ga means geographic atrophy, which is an area of tissue loss in the retina, the light-sensitive part of the eye.

    The study also measures changes in vision in the study eye from baseline through month 18 using several vision tests: bcva (best corrected visual acuity, meaning the clearest vision possible with glasses or contact lenses), llva (low luminance visual acuity, meaning vision tested in dim light), qcsf (a test that measures how well you can see contrast), and lcqva (low contrast quantitative visual acuity, meaning vision tested with low-contrast letters).

    The study records whether you lose 15 or more letters on a vision test compared with baseline.

    The study also measures changes in the area of the ellipsoid zone in the macula. The macula is the central part of the retina used for sharp central vision, and the ellipsoid zone is a layer seen on eye scans.

  4. Step 4

    Safety checks during the study

    Your safety is checked during the study by recording eye-related and non-eye-related side effects.

    The study also includes safety checks using physical examinations, vital signs such as blood pressure, pulse, and temperature, ecg (electrocardiogram, a test that records the heart's electrical activity), and laboratory tests.

  5. Step 5

    End of the study period

    The study period for the main eye measurement lasts through month 18.

    One endpoint is the change in ga lesion area from baseline through month 00, as listed in the source data.

Who can join the trial?

7 criteria

  • Be a man or woman who is 50 years of age or older.
  • Have a diagnosis of geographic atrophy secondary to age-related macular degeneration in at least one eye. Geographic atrophy means an area of damage or thinning in the back part of the eye, and age-related macular degeneration is an eye condition that affects central vision.
  • For the eye that will be studied, the total size of the geographic atrophy area, measured with a special eye scan called FAF (fundus autofluorescence, a picture that helps show damaged areas in the retina), must be at least 2.5 mm² and no more than 17.5 mm².
  • If the geographic atrophy is made up of more than one separate area, the total combined size must still be between 2.5 mm² and 17.5 mm², and at least one separate area must be at least 1.25 mm².
  • The entire geographic atrophy area must be visible on the eye image centered on the macula (the central part of the retina that helps with sharp, straight-ahead vision).
  • The geographic atrophy area must not touch peripapillary atrophy, which means thinning or damage around the optic nerve area at the back of the eye.
  • The study eye must have best-corrected visual acuity of at least 35 letters on the ETDRS chart, which is an eye chart used to measure vision, equal to about 20/200 vision or better.

Who cannot join the trial?

8 criteria

  • Any choroidal neovascularization in either eye, meaning new abnormal blood vessels under the retina, or current signs of this condition at screening.
  • Any exudative macular neovascularization in either eye, meaning leaking abnormal blood vessels in the macula, the central part of the retina needed for sharp vision.
  • Use of a complement inhibitor by injection into the eye in either eye within the past 3 months, or within 5 drug half-lives from screening, whichever is longer. A complement inhibitor is a medicine that blocks part of the immune system.
  • Having received 6 or more doses of an injected anti-complement treatment in the study eye.
  • Any previous cell therapy or gene therapy in either eye. Cell therapy uses living cells as treatment, and gene therapy changes genes to treat disease.
  • Macular atrophy in either eye caused by a condition other than age-related macular degeneration, such as Stargardt disease, cone rod dystrophy, or toxic maculopathies. Macular atrophy means loss or thinning of tissue in the macula.
  • Eye surgery in the study eye within 3 months before the starting visit, including cataract surgery or vitreoretinal surgery. Cataract surgery removes the cloudy lens, and vitreoretinal surgery is surgery inside the eye involving the retina and vitreous gel.
  • Any significant problem that makes it hard to see the back of the eye clearly or may affect image quality, such as cloudy eye tissue, nystagmus (uncontrolled eye movements), severe drooping of the eyelid, limited eye movement, or head tremor.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

FWY003 is the study medicine being tested in this trial. It is taken by mouth as a capsule. The goal of the study is to see whether FWY003 can help slow the growth of geographic atrophy lesions in people with age-related macular degeneration, and to check how safe it is and how well it works.

What is already known about the treatment

FWY003 tosylate - FWY003 tosylate is an oral capsule taken by mouth, which means it is swallowed rather than injected or applied to the eye. It is an investigational medicine, so its full place in routine medical care and the published medical literature is still limited, and it is being studied in people with geographic atrophy caused by age-related macular degeneration. Based on the trial goal, it is intended to slow the loss of retinal tissue in the eye, but its exact molecular action is not yet well established; it is being evaluated as a targeted drug that may affect the disease process that leads to cell damage and tissue loss. Its pharmacological class is not yet clearly defined in standard medicine, because it is still an experimental treatment rather than an approved therapy.

Investigated diseases

Geographic atrophy secondary to age-related macular degeneration - A form of age-related macular degeneration in which areas of the central retina gradually waste away. It usually develops slowly, with patches of damaged tissue becoming larger over time. As the affected area expands, central vision can become more affected, and nearby retinal layers may also thin.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523704-77-00Protocol codeCFWY003A12201Estimated enrolment272 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).