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

Официальное название

A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

Обзор

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

Подробное описание

This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.

Вмешательства

• Препарат FWY003
  FWY003 arm participants will receive a specific dose of FWY003
• Препарат Placebo
  Placebo arm participants will receive placebo

Первичные конечные точки

• Change of geographic atrophy (GA) lesion area [Срок оценки: From Baseline to Month 18]

Вторичные конечные точки (11)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: From first dose (Day 1) to Month 19]
• Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA) [Срок оценки: Baseline through Month 18]
• Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA) [Срок оценки: Baseline through Month 18]
• Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance [Срок оценки: Baseline through Month 18]
• Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance [Срок оценки: Baseline through Month 18]
• Change in visual function measure by LCqVA under low luminance [Срок оценки: Baseline through Month 18]
• Proportion of participants with ≥15 letters loss [Срок оценки: Baseline through Month 18]
• Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula [Срок оценки: Baseline through Month 18]
• Plasma concentrations of FWY003 [Срок оценки: Baseline through Month 18]
• Rate of change of GA lesion area (square-root transformed) in the study eye [Срок оценки: Baseline through Month 18]
• Change of GA lesion area (square-root transformed) [Срок оценки: Baseline through Month 12]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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 visualization or interfere with retinal imaging data quality.

Other protocol-defined inclusion/exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Salehi Retina Institute — Huntington Beach
• Retinal Consultants Medical Group Inc — Sacramento
• California Retina Consultants — Santa Barbara
• Advanced Research LLC — Boynton Beach
• Advanced Research LLC — Deerfield Beach
• Retina Vitreous Associates of Florida — St. Petersburg
• Opthamalic Consultants of Boston — Boston
• NJ Retina — Toms River
• … и ещё 7 центров

Австралия · 4 центра

• Novartis Investigative Site — Albury
• Novartis Investigative Site — Parramatta
• Novartis Investigative Site — Strathfield
• Novartis Investigative Site — East Melbourne

Франция · 4 центра

• Novartis Investigative Site — Lyon
• Novartis Investigative Site — Créteil
• Novartis Investigative Site — Dijon
• Novartis Investigative Site — Paris

Германия · 4 центра

• Novartis Investigative Site — Bonn
• Novartis Investigative Site — Ludwigshafen
• Novartis Investigative Site — Münster
• Novartis Investigative Site — Tübingen

Италия · 4 центра

• Novartis Investigative Site — Florence
• Novartis Investigative Site — Milan
• Novartis Investigative Site — Milan
• Novartis Investigative Site — Roma

Испания · 4 центра

• Novartis Investigative Site — Santiago Compostela
• Novartis Investigative Site — Sant Cugat Del V
• Novartis Investigative Site — Burjassot
• Novartis Investigative Site — Córdoba

Венгрия · 3 центра

• Novartis Investigative Site — Pécs
• Novartis Investigative Site — Debrecen
• Novartis Investigative Site — Budapest

Канада · 2 центра

• Novartis Investigative Site — London
• Novartis Investigative Site — Ottawa

Чехия · 2 центра

• Novartis Investigative Site — Prague
• Novartis Investigative Site — Prague

Польша · 2 центра

• Novartis Investigative Site — Bydgoszcz
• Novartis Investigative Site — Krakow

Румыния · 2 центра

• Novartis Investigative Site — Cluj-Napoca
• Novartis Investigative Site — Bucharest

Великобритания · 2 центра

• Novartis Investigative Site — Bristol
• Novartis Investigative Site — London

Болгария · 1 центр

• Novartis Investigative Site — Sofia

Япония · 1 центр

• Novartis Investigative Site — Bunkyo Ku

Пуэрто-Рико · 1 центр

• Emanuelli Research and Development Center LLC — Arecibo

Идентификаторы

NCT: NCT07441642 · CFWY003A12201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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