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New drug FWY003 aims to halt blinding eye disease

NCT ID NCT07441642

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This Phase 2 trial tests FWY003, an experimental drug, in 272 people with geographic atrophy (a form of advanced age-related macular degeneration). The goal is to see if different doses can slow the growth of damaged areas in the eye and preserve vision. Participants receive either FWY003 or a placebo by injection, and researchers will monitor safety and changes in eyesight over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FWY003
What this could lead to
If successful, this could lead to a treatment that slows vision loss from geographic atrophy, helping people with age-related macular degeneration maintain sight longer.
What could go wrong
This is an early Phase 2 trial with only 272 participants, so results may not confirm effectiveness. The drug may not slow disease progression or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 272 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Male or female participants ≥ 50 years of age. * A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye. 1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively) 2. If GA lesion is multifocal, then the total lesion area must be between 2.5-17.5 mm2 and at least one lesion should have an area of at least 1.25 mm2 3. Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy * ETDRS BCVA ≥ 35 letters (20/200) in the study eye. Exclusion Criteria: * A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye. * Previous cell or gene therapy in either eye. * Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc. * Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline. * Presence of significant media opacity, eye movement disorder (nystagmus), severe ptosis, extraocular motility restriction or head tremor, which in the opinion of the investigator, would prevent adequate fundus visualization or which in the opinion of the Reading Center could interfere with the assessment of study images. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Geographic atrophy secondary to age-related macular degeneration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    55 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Research LLC

    RECRUITING

    Boynton Beach, Florida, 33437, United States

  • Advanced Research LLC

    RECRUITING

    Deerfield Beach, Florida, 33064, United States

  • California Retina Consultants

    RECRUITING

    Santa Barbara, California, 93103, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Emanuelli Research and Development Center LLC

    RECRUITING

    Arecibo, 00612, Puerto Rico

  • Erie Retina Research LLC

    RECRUITING

    Erie, Pennsylvania, 16505, United States

  • Mid Atlantic Retina

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • NJ Retina

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • New York Eye and Ear Infirmary of Mount Sinai

    RECRUITING

    New York, New York, 10003, United States

  • Novartis Investigative Site

    RECRUITING

    Albury, New South Wales, 2640, Australia

  • Novartis Investigative Site

    RECRUITING

    Parramatta, New South Wales, 2150, Australia

  • Novartis Investigative Site

    RECRUITING

    Strathfield, New South Wales, 2135, Australia

  • Novartis Investigative Site

    RECRUITING

    East Melbourne, Victoria, 3002, Australia

  • Novartis Investigative Site

    RECRUITING

    Sofia, 1618, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    London, Ontario, N6A 4L8, Canada

  • Novartis Investigative Site

    RECRUITING

    Ottawa, Ontario, K2B 7E9, Canada

  • Novartis Investigative Site

    RECRUITING

    Barranquilla, Atlántico, 080001, Colombia

  • Novartis Investigative Site

    RECRUITING

    Prague, 100 34, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    RECRUITING

    Lyon, Rhone, 69004, France

  • Novartis Investigative Site

    RECRUITING

    Créteil, 94000, France

  • Novartis Investigative Site

    RECRUITING

    Dijon, 21000, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75940, France

  • Novartis Investigative Site

    RECRUITING

    Ludwigshafen, Germany, 67063, Germany

  • Novartis Investigative Site

    RECRUITING

    Bonn, 53105, Germany

  • Novartis Investigative Site

    RECRUITING

    Münster, 48145, Germany

  • Novartis Investigative Site

    RECRUITING

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    RECRUITING

    Pécs, Baranya, 7621, Hungary

  • Novartis Investigative Site

    RECRUITING

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    RECRUITING

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    RECRUITING

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00184, Italy

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 1138655, Japan

  • Novartis Investigative Site

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631, Poland

  • Novartis Investigative Site

    RECRUITING

    Krakow, 31-070, Poland

  • Novartis Investigative Site

    RECRUITING

    Cluj-Napoca, Cluj, 400006, Romania

  • Novartis Investigative Site

    RECRUITING

    Bucharest, 011658, Romania

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    Sant Cugat Del V, Barcelona, 08190, Spain

  • Novartis Investigative Site

    RECRUITING

    Burjassot, Valencia, 46100, Spain

  • Novartis Investigative Site

    RECRUITING

    Córdoba, 14012, Spain

  • Novartis Investigative Site

    RECRUITING

    Bristol, BS1 2LX, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, NW10 7NS, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • Opthamalic Consultants of Boston

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Retina Consultants TX Rsrch Ctr

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Houston PA

    RECRUITING

    Houston, Texas, 77030, United States

  • Retina Consultants of Texas

    RECRUITING

    Katy, Texas, 77494, United States

  • Retina Vitreous Associates of Florida

    RECRUITING

    St. Petersburg, Florida, 33711, United States

  • Retinal Consultants Medical Group Inc

    RECRUITING

    Sacramento, California, 95841, United States

  • Salehi Retina Institute

    RECRUITING

    Huntington Beach, California, 92647, United States

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