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Набира участници Фаза 3 NCT07064759

Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Фаза 3 – широко изпитване преди одобрение
Заболявания: Neovascular Age-Related Macular Degeneration (nAMD)

Спонсор: 4D Molecular Therapeutics

Налично на: БГ
Обобщение
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Кой може да участва
Inclusion Criteria: * ≥50 years of age at time of consent * MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator * Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center * Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center * BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit * CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center Exclusion Criteria: Ocular Conditions: * MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter) * History of retinal detachment in the study eye * History of or presence of active inflammation in either eye * Glaucoma or intraocular hypertension requiring more than 2 topical medications for control Ocular Treatments/Interventions: * Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye Systemic Conditions and Considerations: * Major illness or major surgical procedure in the 28 days prior to the Screening Visit * Uncontrolled blood pressure * Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit * History of autoimmune condition that may predispose to the development of uveitis
Места на провеждане 14
Argentina (1)
Grupo Láser Visión
Rosario , Santa Fe Province
Австралия (1)
Adelaide Eye and Retina Centre
Adelaide
България (1)
Zora Eye Hospital
Sofia
Германия (1)
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf
Унгария (1)
Bajcsy-Zsilinszky Kórház
Budapest
Италия (1)
AOU delle Marche
Ancona
Япония (1)
Kozawa Eye Hospital and Diabetes Center
Mito , Ibaraki
Latvia (1)
P.Stradins University Hospital
Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences
Kaunas
Португалия (1)
Aibili - Cec
Coimbra
Сингапур (1)
Singapore Eye Research Institute (SERI)
Singapore
Испания (1)
Miranza Instituto Gomez-Ulla
Santiago de Compostela , Spain
Великобритания (1)
Bradford Royal Infirmary
Bradford , UK
САЩ (1)
Research Network Arizona
Scottsdale , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
50 Years
Здрави доброволци
Не
Начална дата
22.07.2025
Крайна дата
01.02.2029
Регистрационен номер
NCT07064759
Източник
anzctr
Запитване за медицински туризъм

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