Study Description
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 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
FWY003
Placebo
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.
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 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 ≥ 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.
Novartis Investigative Site
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Parramatta,New South Wales,2150,Australia
Novartis Investigative Site
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Albury,New South Wales,2640,Australia
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East Melbourne,Victoria,3002,Australia
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Strathfield,New South Wales,2135,Australia
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Sofia,1618,Bulgaria
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Ottawa,Ontario,K2b 7e9,Canada
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Prague,100 34,Czechia
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Prague,128 08,Czechia
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Paris,75940,France
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Lyon,Rhone,69004,France
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Créteil,94000,France
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Tübingen,72076,Germany
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Bonn,53105,Germany
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Pécs,Baranya,7621,Hungary
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Roma,RM,00184,Italy
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Milan,MI,20132,Italy
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Krakow,31-070,Poland
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Bydgoszcz,Kuyavian-Pomeranian Voivodeship,85 631,Poland
Novartis Investigative Site
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Bucharest,011658,Romania
Novartis Investigative Site
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Cluj-Napoca,Cluj,400006,Romania
Novartis Investigative Site
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Burjassot,Valencia,46100,Spain
Erie Retina Research LLC
Recruiting
Erie,Pennsylvania,16505,United States
Jade Horn
David Almeida
New York Eye and Ear Infirmary of Mount Sinai
Recruiting
New York,New York,10003,United States
Richard Rosen
Columbia University Medical Center
Recruiting
New York,New York,10032,United States
Tongalp Tezel
California Retina Consultants
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Santa Barbara,California,93103,United States
Dante Pieramici
NJ Retina
Recruiting
Toms River,New Jersey,08755,United States
Howard Fine
Salehi Retina Institute
Recruiting
Huntington Beach,California,92647,United States
Hani Salehi-Had
Advanced Research LLC
Recruiting
Boynton Beach,Florida,33437,United States
Alayka Reddy
Drew Philip Bawcombe
Advanced Research LLC
Recruiting
Deerfield Beach,Florida,33064,United States
Shailesh Gupta
Opthamalic Consultants of Boston
Recruiting
Boston,Massachusetts,02114,United States
Jeffrey S Heier
Retina Vitreous Associates of Florida
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St. Petersburg,Florida,33711,United States
David Eichenbaum
Retina Consultants TX Rsrch Ctr
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Bellaire,Texas,77401,United States
David M Brown
Retina Consultants of Texas
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Katy,Texas,77494,United States
Kenneth Fan
Kymmia Majedi
Retinal Consultants Medical Group Inc
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Sacramento,California,95841,United States
Margaret Chang
Retina Consultants of Houston PA
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Houston,Texas,77030,United States
Charles C Wykoff
Erin Shelato
Worldwide Contacts
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