Идёт набор NCT07064759

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

Фаза III С лечением Neovascular Age-Related Macular Degeneration (nAMD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 4D-150 IVT (3E10 vg/eye), EYLEA® (aflibercept) Injection 2 mg (0.05mL).
Кому может быть актуально: Состояния в реестре: Neovascular Age-Related Macular Degeneration (nAMD). Базовые параметры: от 50 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Болгария, Германия +9
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Обзор

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Вмешательства

Биопрепарат 4D-150 IVT (3E10 vg/eye)
If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1
Биопрепарат EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea (aflibercept) will be administered at applicable visits

Первичные конечные точки

Mean change from baseline in Best Corrected Visual Accuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52 [Срок оценки: 52 Weeks]

Вторичные конечные точки (5)

Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104 [Срок оценки: 104 Weeks]
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104 [Срок оценки: 104 Weeks]
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm [Срок оценки: 104 Weeks]
Mean change from baseline in Central Subfield Thickness (CST) over time through Weeks 52 and 104 [Срок оценки: 104 Weeks]
Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104 [Срок оценки: 104 Weeks]

Критерии участия

Критерии включения

≥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:

Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
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

Критерии исключения

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

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: Четверное слепое
Основная цель: Лечение

Центры проведения

США · 54 центра

Research Network Arizona — Scottsdale
Barnet Dulaney Perkins Eye Center — Sun City
Retina Associates — Tucson
Retinal Diagnostic Center — Campbell
Retina Consultants of Orange County — Fullerton
Northern California Retina Vitreous Associates — Mountain View
Retinal Consultants Medical Group Inc. — Sacramento
Retinal Consultants Medical Group — Sacramento
… и ещё 46 центров

Аргентина · 6 центров

Grupo Láser Visión — Rosario
Microcirugia Ocular Rosario — Rosario
Centro Privado de Ojos — Buenos Aires
Charles Research Center — Buenos Aires
OFTALMOS — Buenos Aires
Centrovisión — Mendoza

Венгрия · 6 центров

Bajcsy-Zsilinszky Kórház — Budapest
Budapest Retina Associates — Budapest
Semmelweis Egyetem - Szemészeti Klinika — Budapest
DE KK Ophthalmology Clinic — Debrecen
Ganglion Medical Center — Pécs
SzTE SZAKK Szemeszeti Klinika — Szeged

Япония · 5 центров

Kozawa Eye Hospital and Diabetes Center — Mito
University of the Ryukyus Hospital — Ginowan
Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital — Fukuoka
Hayashi Eye Hospital — Fukuoka
National Hospital Organization Tokyo Medical Center — Tokyo

Австралия · 4 центра

Adelaide Eye and Retina Centre — Adelaide
Eye Clinic Albury Wodonga — Albury
Strathfield Retina Clinic — Strathfield
Sydney Retina Clinic and Day Surgery — Sydney

Германия · 3 центра

Internationale Innovative Ophthalmochirurgie GbR — Düsseldorf
Augenzentrum Frankfurt — Frankfurt
Dietrich Bonhoeffer Klinikum — Neubrandenburg

Латвия · 3 центра