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Recruiting NCT07441642

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

Phase II Interventional Geographic Atrophy Secondary to Age-related Macular Degeneration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FWY003, Placebo.
Who it may be relevant to
Registry conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Bulgaria, Canada, Czechia +10
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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

Interventions

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

Primary outcome measures

  • Change of geographic atrophy (GA) lesion area [Time frame: From Baseline to Month 18]
Secondary outcome measures (11)
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Time frame: From first dose (Day 1) to Month 19]
  • Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA) [Time frame: Baseline through Month 18]
  • Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA) [Time frame: Baseline through Month 18]
  • Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance [Time frame: Baseline through Month 18]
  • Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance [Time frame: Baseline through Month 18]
  • Change in visual function measure by LCqVA under low luminance [Time frame: Baseline through Month 18]
  • Proportion of participants with ≥15 letters loss [Time frame: Baseline through Month 18]
  • Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula [Time frame: Baseline through Month 18]
  • Plasma concentrations of FWY003 [Time frame: Baseline through Month 18]
  • Rate of change of GA lesion area (square-root transformed) in the study eye [Time frame: Baseline through Month 18]
  • Change of GA lesion area (square-root transformed) [Time frame: Baseline through Month 12]

Eligibility criteria

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.
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 15 centers
  • 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
  • … and 7 more centers
Australia · 4 centers
  • Novartis Investigative Site — Albury
  • Novartis Investigative Site — Parramatta
  • Novartis Investigative Site — Strathfield
  • Novartis Investigative Site — East Melbourne
France · 4 centers
  • Novartis Investigative Site — Lyon
  • Novartis Investigative Site — Créteil
  • Novartis Investigative Site — Dijon
  • Novartis Investigative Site — Paris
Germany · 4 centers
  • Novartis Investigative Site — Bonn
  • Novartis Investigative Site — Ludwigshafen
  • Novartis Investigative Site — Münster
  • Novartis Investigative Site — Tübingen
Italy · 4 centers
  • Novartis Investigative Site — Florence
  • Novartis Investigative Site — Milan
  • Novartis Investigative Site — Milan
  • Novartis Investigative Site — Roma
Spain · 4 centers
  • Novartis Investigative Site — Santiago Compostela
  • Novartis Investigative Site — Sant Cugat Del V
  • Novartis Investigative Site — Burjassot
  • Novartis Investigative Site — Córdoba
Hungary · 3 centers
  • Novartis Investigative Site — Pécs
  • Novartis Investigative Site — Debrecen
  • Novartis Investigative Site — Budapest
Canada · 2 centers
  • Novartis Investigative Site — London
  • Novartis Investigative Site — Ottawa
Czechia · 2 centers
  • Novartis Investigative Site — Prague
  • Novartis Investigative Site — Prague
Poland · 2 centers
  • Novartis Investigative Site — Bydgoszcz
  • Novartis Investigative Site — Krakow
Romania · 2 centers
  • Novartis Investigative Site — Cluj-Napoca
  • Novartis Investigative Site — Bucharest
United Kingdom · 2 centers
  • Novartis Investigative Site — Bristol
  • Novartis Investigative Site — London
Bulgaria · 1 center
  • Novartis Investigative Site — Sofia
Japan · 1 center
  • Novartis Investigative Site — Bunkyo Ku
Puerto Rico · 1 center
  • Emanuelli Research and Development Center LLC — Arecibo

Identifiers

NCT: NCT07441642 · CFWY003A12201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗