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Compares treatment options for Geographic Atrophy Secondary to Age-related Macular Degeneration
Official title A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT07441642
What this study is testing
What is FWY003?
FWY003 is an investigational medicine, being studied as a potential treatment for geographic atrophy secondary to age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
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). If both eyes qualify, then the eye with the better BCVA would be assigned as...
- Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)
- 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
- Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy
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...
- 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...
See the full eligibility 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.
- Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)
- 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
- 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.
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Huntington Beach, California, United States
- Sacramento, California, United States
- Santa Barbara, California, United States
- Boynton Beach, Florida, United States
- Deerfield Beach, Florida, United States
- St. Petersburg, Florida, United States
- Boston, Massachusetts, United States
- Toms River, New Jersey, United States
- New York, New York, United States
- Erie, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Bellaire, Texas, United States
- Houston, Texas, United States
- Katy, Texas, United States
- Albury, New South Wales, Australia
- Parramatta, New South Wales, Australia
- Strathfield, New South Wales, Australia
- East Melbourne, Victoria, Australia
- Sofia, Bulgaria
- London, Ontario, Canada
+ 28 more site(s).
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntington Beach, California, United States; Sacramento, California, United States; Santa Barbara, California, United States; Boynton Beach, Florida, United States; Deerfield Beach, Florida, United States; St. Petersburg, Florida, United States and 42 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 ClinicalTrials.gov; the study team decides eligibility.