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โ† Trials
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A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

RecruitingPhase 2Ages 50 Years - anyAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Male or female participants โ‰ฅ 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 โ‰ฅ2.5 and โ‰ค17.5 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 โ‰ฅ 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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What it tests

  • FWY003
  • Placebo
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Where

59 sites
Salehi Retina Institute
Huntington Beach, United States
Retinal Consultants Medical Group Inc
Sacramento, United States
California Retina Consultants
Santa Barbara, United States
Advanced Research LLC
Boynton Beach, United States
Advanced Research LLC
Deerfield Beach, United States
Retina Vitreous Associates of Florida
St. Petersburg, United States
Opthamalic Consultants of Boston
Boston, United States
NJ Retina
Toms River, United States

โ€ฆand 51 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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