Authorised Therapeutic exploratory (Phase II) Geographic atrophy secondary to age-related macular degeneration

A clinical trial to learn more about the effects of FWY003 in people with geographic atrophy associated with age-related macular degeneration.

EU CTIS ID: 2025-523704-77-00

What this study is testing

To evaluate the dose response relationship of FWY003 on GA lesion area in participants with GA secondary to AMD

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male or female participants ≥ 50 years of age.
  • A diagnosis of GA secondary to AMD in at least one eye (study eye) MUST meet the following criteria with lesion size assessed by FAF. 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 with 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.

You likely can't join if

  • A history of, or current evidence of, choroidal neovascularization (exudative MNV) in either eye, as determined by the central reading center on multimodal imaging at screening.
  • Intravitreal drug delivery of a complement inhibitor in either eye in the past 3 months or 5 half-lives from screening (whichever is longer). The study eye should not have received ≥6 doses of intravitreally administered anti-complement therapies.
  • 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 interfere with retinal imaging data quality.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • Canada
  • Colombia
  • New Zealand
  • Brazil
  • Japan
  • Argentina
  • United States
  • Australia
  • China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Canada; Colombia; New Zealand; Brazil; Japan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.